Regulatory Affairs

Our team here at Adaptive Life Science understand the importance having a strong product management team in place.

We are constantly networking, speaking to and building relationships with the top Product Leaders, Product Owners/Manager, Scrum Masters & Agile Coaches, as well as UX/UI-Designers and other Product Experts. 

Our specialist focus in the MedTech sector means that all of our client and candidate relationships are with traditional medical devices and/or digital health products. 

We understand the importance of cultural fit and communication style for product teams, and take this into high consideration when matching professionals in this space with possible companies.

Traditional Medical Devices
Adaptive’s highly experienced consultants have grown an extensive network of top professionals and medical device manufacturers.

We support product professionals with experience in all areas of the Medial Device space including Class I – III products, IVDs, Software, Invasive and Non-Invasive Devices, as well as Prosthetics and Implants.

Digital Health
​The Digital Heath Sector is one of the fastest growing sectors within Healthcare, if not the fastest, and the global pandemic has only helped accelerate it. 

​Whether it’s a DiGA, new product coming to market, device utilizing AI or VR, we know them all and the companies offering innovation and creative freedom. 

From VC backed start-ups to global players entering the digital health space, we have options to suit your style and product interests. 

For our clients in digital health, we’re in contact with professionals across the wide spectrum of product management, from technical (with a track record of managing product development and design, including the planning process) to UX/UI, product growth and owners responsible for an entire app.

Active jobs

Regulatory Affairs Manager

Tuttlingen
Germany
60,000EUR - 70,000EUR
Regulatory Affairs Officer Overview Are you looking for a new challenge in regulatory affairs? I am currently supporting a client who specializes in sleep diagnostics in southern Germany in hiring an expert in EU MDR, approval processes, IEC 60601, IEC 62304 and ISO 14971. This is a hybrid working position where you can work 2/3 days from home. Tasks Implementation and maintenance of regulatory approval of medical devices in accordance with EU MDR Assisting in the compilation of documentation and supporting in the creation and maintenance of risk management files in accordance with ISO 14971 and usability files in accordance with IEC 62366-1 Support international distributors in the approval process of the medical devices PMS activities such as PMS files and vigilance investigations Your profile Experience in areas such as regulatory affairs or technical documentation in the MedTech or medical device industry Solid foundational knowledge of relevant regulatory and normative requirements (MDD, MDR, ISO 13485 etc.) IT Skills such as MS Office Good communication and organizational skills as well as independence and reliability Fluency in English and German Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

Senior Vigilance and PMS Specialist

Munich
Germany
70,000EUR - 85,000EUR
Senior PMS & Vigilance Specialist Are you a competitive spirit, looking for the next challenge to conquer? Do you believe that effective teamwork can propel you further than you could ever go by yourself? Are you looking for a future-proof workplace where personal and appreciative cooperation is at the core of your employer’s mission? Look no further… Overview: My client is an industry leader in orthopaedic product development and medical education. They are dedicated to delivering top-quality solutions for healthcare professionals and the countless patients benefiting from their devices. Tasks: Creation and submission of vigilance reports in the EMEA region Assessment of potentially reportable incidents Processing product complaints, monitoring and coordinating further processes Handling FSCAs Participating in internal and external audits Your Profile: Degree in a scientific, medical or technical field or comparable qualification Experience working with medical devices or similarly regulated products Sound knowledge of handling customer complaints and reportable events per MDR Knowledge of additional international medical device regulatory frameworks are a plus! (e.g. FDA, MDSAP etc.) Fluent written and spoken German and English are a must! Interested?  Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. vivien.urban@adaptivelifescience.com +49 30 16639819 #LI-VU1  

Medical Affairs Director/Senior Manager

Remote
Germany
70,000EUR - 90,000EUR
Medical Affairs Director/Senior Manager Are you an expert in Medical/Clinical Affairs in Class III Implantable Devices? Are you looking to take your next step into a leadership role? Do you want to work with a global technology leader in regenerative medicine? We are currently supporting our client headquartered in Germany to strengthen their clinical/medical affairs function. This is a remote role, so you can be based anywhere in Germany but must be willing to travel from time to time. Does this sound like your next career step? Tasks Management of a small team (2-5 employees) Ensure regulatory compliance for clinical trials and medical products on the market in accordance to MDR, TGA and FDA Pre-market and post-market clinical projects, including medical writing, CERs, PMS, and PMCFs Clinical trial project management (documentation, budget planning, collaboration with stakeholders on an international level as well as CROs) Reimbursement and compliance (Europe, especially Germany) Your profile Degree in a scientific field such as biomedical, biology, medicine, medical engineering or a comparable field of study Experience in clinical (e.g. CER), regulatory affairs, bio-medical publication or medical writing, especially for class III implants Strong communication skills and project management experience Team player who can also work independently Knowledgeable in MS Office Fluency in English, German is a bonus Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

Senior Clinical Affairs Specialist

Munich
Germany
65,000EUR - 80,000EUR depeding on experience
Senior Clinical Affairs Specialist Are you interested in joining an award-winning company who are innovating in the field of cardiotherapy? Are you experienced with pre-market and post-market clinical studies for active medical devices up to class III? We're currently supporting a client in the medical device industry who are head-quartered just outside of Munich and are looking to strengthen their Clinical Affairs function. This is a hybrid position, so you must be accessible to the site. Could you be their new Senior Clinical Affairs Specialist? Tasks Responsible for the strategy and execution of clinical evaluation for medical devices up to Class III Look after the conception and the evaluation of follow-up studies Collaborate with clinical partners for various research projects Provide scientific input while supporting other areas of the organization Provide mentorship and sharing your expertise with colleagues Your profile Degree in a technical or scientific field, ideally in the direction of medical technology Several years of experience in clinical evaluation and follow-up of active medical devices up to class III Solid foundational knowledge of relevant regulatory and normative requirements (MDR, ISO 14155, MDCG Guidance etc.) Team player who can also work independently Eager to learn attitude and willingness to share your knowledge Fluency in German and English Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

Regulatory Affairs Specialist

Heidelberg
Germany
€65,000
Regulatory Affairs Specialist Are you passionate about bringing safe and effective medical devices to market with speed and agility? My client, a global leader in the design, manufacture, and distribution of cutting-edge mobility devices is seeking a promising Regulatory Affairs Specialist to join their European team. Ready to put your skills to work? Your Tasks: Implement quality system components focused on regulatory compliance with MDR 2017/745, ISO 13485 and ISO 14971 Manage projects and activities for the improvement of products and processes from a regulatory standpoint Monitor and ensure the compliance of regulatory requirements (Europe, Switzerland & UK) Manage CAPA system, track recalls and FSCAs Participate in risk assessment activities such as UFMEA Collaborate with the Quality Director Europe to ensure documentation is compliant Assist in liability claim investigation and document collection Your profile: Fluent in English and at least intermediate knowledge of German 2+ years professional experience in regulatory affairs or quality management relating to medical devices Thorough knowledge of regulatory requirements (e.g. MDR, ISO 13485 & ISO 14971) Computer proficiency with MS Office Strong communication skills, good organizational skills, analytical thinking and a high level of reliability Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. vivien.urban@adaptivelifescience.com +49 30 16639819 #LI-VU1

Senior RA Specialist

Jena
Germany
60,000EUR - 70,000EUR
Senior Regulatory Affairs Specialist Location:   Would you like to work for a global healthcare leader in point of care diagnostics?  We are currently supporting our client who is looking for a Senior Regulatory Affairs Specialist to join their Diagnostics Division in Jena, Germany. Your tasks: Preparing and submitting technical files and communications to the Notified Body and regulatory agencies Supporting the regulatory department for efficient and compliant business processes Contributing to process/product improvement projects and risk management Assisting with label development and review for compliance Building strong relationships with internal and external stakeholders Your profile: Bachelor’s degree (BA/BS) from an accredited University Minimum of 2 years experience working in Regulatory Affairs with medical devices (e.g. with MDR or IVDR) Strong communication skills in English and German Strong attention to detail and a positive, flexible mindset Team player, preferably with experience in project- and team management Basic understanding of IVD regulation and experience generating quality documentation is a plus! Benefits: Meaningful Impact: contribute to improving patient well-being Career Growth: international opportunities in a fast-growing industry Attractive Benefits: comprehensive package including pension and stock options Global Recognition: join a globally recognized, diverse, and inclusive workplace Collaborative Environment: work with a dynamic, skilled team in an open and efficient culture If you feel this role was made for you, apply with your CV or contact Vivien Urban for further details or additional vacancies in the MedTech industry. No CV? No problem - you can leverage your LinkedIn profile instead. vivien.urban@adaptivelifescience.com #LI-VU1

Risk Manager

Frankfurt
Germany
60,000EUR - 80,000EUR
Risk Manager Location: Frankfurt area (high degree of remote flexibility) Would you like to work for a global leader in the treatment of renal disease and support the safety of the product through a risk management process? We are currently supporting our client who is looking for a Risk Manager to join their Product Development Team. Your tasks: Plan and execute the risk management process. Create risk assessments for complaints and support the preparation of FMEAs. Support the audit of design & development and risk management sessions. Create and monitor the design control metrics in development, post-market activities, and change management. Monitor the state of the art to continuously improve product safety. Responsible for pre-production defect management (Anomaly Reports), risk analysis, and specification of countermeasures. Your profile: A degree in engineering, biology, medical technology, or equivalent. Minimum of 3 years of experience in Regulatory Affairs, Research and Development, or Risk Management. Experienced in medical device regulations (EU MDR, MDSAP, MDD 93/42/EEC, etc.) High degree of knowledge in FMEA method, and quality management and risk management standards (ISO 13485 and ISO 14971). Fluent in written and spoken English and advantage of German skills. Benefits: Very international environment. High home office flexibility and flexible working hours. Continuous support in the development. Pension scheme. Please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in Medical Technology. Dominika.Wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Remote

Regulatory Affairs Manager

Greater Freiburg Area
Germany
80,000EUR
Regulatory Affairs Expert   Do you enjoy working with many different clients, ensuring their regulatory compliance as well as supporting them in achieving their CE-marking across the European market? Read on! Our client – a well-established Consultancy is currently looking for a Regulatory Affairs Expert to strengthen their international team.   Responsibilities: Compilation of Technical Documentations. Ensure fulfilment of EU requirements (93/42/EEC, 98/79/EC, 90/385/EEC) as well as new EU regulations 2017/745 und 2017/746. Interactive collaboration with In-house experts covering all subjects related to CE-marking of medical devices /IVDs (pre-clinicians, clinicians, QM etc.) Implement and maintain regulatory SOPs within ISO 13485. Close interaction with international clients as well as Notified Bodies and Competent Authorities. Development of creative solutions in order to fulfil client needs combined with regulatory requirements.   Requirements A degree in electrical, medical/biomedical engineering. Experience in medical device or IVD industry, preferably in regulatory affairs and/or quality management related positions; Notified Body experience Working knowledge of Electrical safety for medical device norm (IEC 60601) Previous experience supporting international registrations to include 510k. Working knowledge of ISO 14971 & IEC 62304.   If you are interested, please apply with your CV or email Dominika Wyrwinska on dominika.wyrwinska@adaptivelifescience.com.. #LI-DW1      

Read our Blogs

09. 09. 2021

Why you should talk to a Recruiter

I’m happy and not looking for a new job right now. Why should I connect with a recruiter?Another InMail in your inbox… beginning to feel a little fed up? You’re not actively searching for a new opportunity so why should you spend your time answering recruiters and connecting on a call with them?Read on to find out why it might be more beneficial to connect than you think…*N.B. Before we get started, it’s important to clarify that I don’t recommend being in touch with every recruiter that contacts you, especially if their message isn’t personal to you or job offers irrelevant, and certainly not if their outreach includes ‘send me a CV’. I’m talking about connecting with the good ones who try to make a deeper connection, focus on you as an individual, and work in your specialist area.   Thinking ahead. Sure, you’re not looking for the next opportunity right now. You have a project that you worked so hard on, and you just cannot imagine leaving before it’s finalised. But what about 6 months, or a year down the line? Situations can and do change and wouldn’t it be great if you had already connected with someone who had asked you those all-important questions and knew about your interests, wants and, not only that, your personal requirements, the locations that fit best and the flexibility you need to fit around your family life. It’s never a bad idea for someone to know these things and have you in mind for when a great opportunity comes up. What’s even better? When the time comes to consider a new opportunity, which it likely will someday, you might not even have to search at all if someone with all this knowledge is doing so already. Give yourself visibility.Some individuals believe that there is little point in connecting with a recruiter; in their mind they think, “if I want to find a job, I can simply look online for job advertisements!” - but did you know that a huge number of job opportunities are not even advertised? Many companies rely on recruiters to support them as it saves a lot of time having to filter through huge pools of candidates who may not be the right fit for the position. This means that your dream job could be waiting for you to be discovered but you would never even know. Clarity.Even if you are not actively looking, speaking to a recruiter about your career, sharing more on the aspects of your career that you love and the elements that perhaps aren’t so satisfactory can really help to you to clarify things and realise what you want. A good recruiter doesn’t have the sole aim to just place you at a company and move on, a good recruiter wants to build long-term relationships and will take time to understand your goals and help you get closer to achieving them – they are passionate about driving your career forward. Take time to connect with a trusted recruiter and you will reap the benefits. It’s a common feedback after an initial conversation that voicing things really helped a candidate to visualise what could be next for them in their career pathway.  Support.If you do decide to explore an opportunity through a recruiter, you’ll have a support system throughout the entire process. Someone on your side with “insider knowledge” about the company, who can prep you before any interaction, tell you all about the personalities of the hiring managers and share information with you about the interview structure and questions that will likely be asked - use it to your advantage! This takes away so much pressure and the “fear of the unknown” that you usually have before that first meeting with an interviewer, allowing you to focus on having those interesting conversations and making new contacts in the industry! Hiring for your own team.Perhaps you really are not considering a new opportunity but are in a leading role at your current company. By connecting with a recruiter, you can see the approach they take to working with candidates and decide if this is someone you want to have onboard to represent the growth of your department. Did they motivate you, show real interest, have industry contacts, and add value to your career even from a first call? Work with this recruiter to meet your company and professional goals! Especially if you are often recruiting in a limited candidate pool, building these contacts and a list of excellent recruitment partners will help speed up the process when you come to hire, since you’ll already know who to trust to get the job done and give candidates an excellent hiring experience. There really is nothing to lose.The bottom line is, there is nothing to lose from connecting with a specialist recruiter in your industry. Avoid buying into the thought process that you should only talk to recruiters if you are actively looking - this is simply not the case (it’s almost better to connect when you’re not in a rush to find a new job). There is no need to feel pressured, as a recruiter will simply be there to ensure that you are informed and have visibility of great opportunities within your industry.  
16. 06. 2021

Navigating Difficult Conversations at Work

Dealing with conflict or tough conversations at work. It’s comparable to the ‘we need to talk’ dread all of us have undoubtedly faced at some point in our personal lives.Whether it’s addressing distracting behaviours in the office, challenging your colleague on the accuracy of a report or confronting a long-overdue company problem – these conversations need to happen, and they need to happen for a few reasons:-         The problem can’t be fixed if there is no awareness of the problem in the first place.-         Get that weight off your shoulders, its liberating!-         It’s how we achieve professional and personal growth – your company will benefit from this too. The art of conversation is like any art. With continued practice you will acquire skill and ease.Finding the right words, and the right moment – it is no easy task in the fast-paced commercial world. Step 1) Conquer your fears and just do it.Here are some tips to make the conversation easier…Set a Positive Tone -         Mindset matters. Frame the conversation in a different way and put a positive spin on it. Be constructive, not negative. Can you offer an alternative solution to the one currently on the table? Make sure there is an action plan in place when a consensus (or even just an understanding) is reached to ensure you move forward.Keep Your Cool-         Don’t forget to breathe! Taking this brief moment to focus on your breathing will allow you to refocus and absorb any information. It’s important that whether you are the recipient or provider of a challenging discussion, that you make a conscious effort to slow down the pace of the conversation, listen, collect your thoughts, and respond rationally.Plan with Emotional Intelligence-         Think ahead. What do you anticipate the response will be to the discussion? Put yourself in the shoes of your counterpart to mentally consider their possible responses. You can have some flexible strategies to hand on how to move the conversation forward in a productive way. If you don’t feel confident on the recipients view beforehand, ask them.Be Concise and Direct-         Difficult conversations need to be clear and to the point, otherwise the message gets lost in a muddled delivery. To avoid receiving objections, be prepared with concrete examples. Focus on facts, not feelings. Try not to let your emotions get the better of you when you are trying to find a resolution.Make It a Conversation-         Feedback shouldn’t be a monologue - there should be two-way communication. Make sure there is an opportunity for an open discussion and questions to allow the meeting to end with unwavering clarity on both sides. Do you fully understand each other and what will happen next?  “Difficulties are meant to rouse, not discourage. The human spirit is to grow strong by conflict.”- William Ellery Channing, American Theologian
10. 06. 2021

Occupational Burnout - Recognizing the signs

“Self-care has become a new priority – the revelation that it’s perfectly permissible to listen to your body and do what it needs.” ― Frances Ryan Burnout - lets talk about it!It’s one of those subjects that often gets mentioned, but never really discussed. I think it’s time to change that.I am actually quite surprised that in today’s day and age it has not been classified as a medical condition yet, because let’s face it – it is.Burnout is very popular and happens more often than people would like to admit. It’s that state of mental, physical, and emotional exhaustion, caused by prolonged, work-related stress. In order to come up with ways of avoiding it, let’s break down the definition to see how each of the factors can be FIXED!Emotional exhaustionEmotional exhaustion is a state of feeling emotionally worn out and drained. This can be easily improved by ensuring we eat right, take technology breaks, meet with our friends, and of course exercise. Yes, many people could argue that exercise is a suggested remedy for almost everything nowadays, but in this case it is true. Exercise releases chemical endorphins to the brain which triggers a positive feeling in your body. So there, we have proof that going for a run or taking that HIIT class is worth it!Mental exhaustionMental exhaustion is similar, but the symptoms can be more severe, as the person experiencing this feeling starts to be detached, showing apathy towards their work colleagues and the work itself. The first thing to do if possible is to remove the stressor. If it is an overwhelming task at work, perhaps speak to your Supervisor – see if they could offer you some help. Don’t feel that you have to go through this alone.Again, try to eat well and stay active, but also practice relaxation techniques like yoga, massage, or mindfulness – all scientifically recognized to lower stress and anxiety.Physical exhaustionPhysical exhaustion is an extreme state of unrelenting fatigue and sometimes it can be brought on by the previously mentioned mental exhaustion. Being in this state can cause dizziness, chronic tiredness, and headaches, which if untreated can lead to moodiness, slow reflexes or even bad judgement/decision making.Get some sleep! Clocking in your 7 - 9 hours of sleep a night can restore well-being. Set aside some time each day to stretch and try eating foods that improve your energy level, like nuts, fish, and cheese. Magnesium is an essential mineral to promote a healthy nervous system, energy production, and for muscle relaxation.Also, if you ever notice that someone around you is starting to display any of the above signs, see if they are ok, offer them help. Trust me, it will make their day!