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

08. 04. 2021

How to answer the question all professionals dread... “What is your dream job?”

I spend 90% of my day getting to know professional candidates across Germany in the field of Medical Devices, especially in roles focussed on Regulatory Affairs and Quality. My primary goal is to get to know you better, and dive-deeper into, well, everything! I am inquisitive about your studies, curious about your thesis topic, why you chose a particular location, your family life, how you have been coping after the numerous lockdowns this year and of course, your career and professional experience. I do not expect to know this all in 30 minutes, which is why I focus much more on the longer-term connection and genuine engagement.We all know that recruiter contact in this highly competitive field is regular, persistent, and sometimes, I imagine, annoying. I’m sure you are getting at least several recruiter messages a week, right? How many of these messages actually fit your expectations or aspirations? I assume not too many…What differentiates our approach at Adaptive Life Science is that we are first and foremost focussed on ‘people relationships’ and ‘result relationships’ second. My aim is to understand you as your friends and colleagues might, so that I can be relevant to your career development and that I always make meaningful contact or at the very least, a nice conversation.How do I do this? It’s all about building a strong relationship from day one, understanding the expectations you have from me as your recruitment partner (long or short term) and asking the question that most candidates dread…“What is your dream job?”Common answers I hear for this are:1) More development opportunities2) A good company culture3) To continue work in RA/QM for medical devices4) Better package5) Rebecca, I have no idea!!If we have spoken before, you’ll know this type of answer won’t make the cut with me.I want to understand the deeper wants and wishes that you need in order for your career to excel. Development means something different to everyone, and as I mentioned we are ‘people first’ so we need to understand YOU. Here are my Top 10 questions to think about to ensure you can easily communicate what you are looking for and ensure you get professional fulfilment from your next job offers…1) Would you like to be more hands-on or strategic in your role, perhaps leading people, or projects?2) Are you more interested in being a specialist in one topic (ie MDR/IVDR transition) or covering worldwide registrations?3) Do you like working broadly across RA/QM or prefer to be more focused on one area of the device lifecycle?4) Are you currently in a large company, or start-up to mid-sized? What are you used to, have you seen the other side and the challenges/possibilities it presents?5) Within RA/QM for Medical Devices is a great start, but please, tell us more! Do you prefer to work in a dual department? Do you have a background in Clinical Research and want to pick up those skills again within RA? These are all viable options so don’t hold back on your ‘wish list.’6) Long term location – have you just built a house or planning to move in the future? How much working flexibility to you need? Is this an absolutely ‘must’ or a nice to have? If this is negotiable, please tell us. Otherwise, we might miss out on sending you an opportunity that ticks 90% of your boxes, that actually meets an even higher standard for you.7) What company culture are you used to, and what do you like about it or not so much? Do you prefer to be structured or free to plan your day? How much support do you really need?8) What products really catch your interest. If you have spent many years in ophthalmic, are you comfortable staying here or do you want a complete change? Would you like to reconnect back with your PhD topic? Tell us things like this and we will always listen.9) Financially, of course the more the better, always! What do you need though? If it is the ‘dream job’ would you consider a more flexible package? Are there any ‘must haves’ like childcare on site, bonus potential, days of vacation? I once had a perfect fit between a client and candidate fall apart right at the end, because she required a certain pension contribution – it was devastating for everyone involved because we did not know it was such an important factor.10) If you are struggling to think of what you do want, tell us what you don’t want! Are there parts of your role that you really don’t enjoy or want less of? This could help to point us in the right direction.It could be that you really are completely open-minded to what is available, and perhaps you are not even looking actively for something new. Either way, in a candidate driven market, you can choose to be selective and make the right choice for you, so it’s important to spend some time reflecting and think about what that is for you personally and professionally so that you can secure your future happiness. It does not mean we will only get in touch if we hit 10/10 on an opportunity, but there is more chance of us getting it right. Life and work are only getting busier, so our aim is to ensure any contact is entirely relevant, interesting and makes it a serious and exciting consideration for you.Thanks for reading and I hope it helps you to reflect over this quieter period about what your ‘dream job’ may, or may not look like.rebecca.stevens@adaptivelifescience.com