Regulatory Affairs

Head of Regulatory Affairs  Location: On-site in Geneva, Switzerland Our client, a leading innovator in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics, is seeking a Head of Regulatory Affairs. This role involves overseeing the EU and US regulatory teams dedicated to Innovation and Life-Cycle projects.  Main Responsibilities: Develop and implement regulatory strategies aligned with business objectives. Oversee regulatory submissions and ensure compliance with EU & US standards. Monitor regulatory changes and adapt strategies accordingly. Collaborate with cross-functional teams on new product development. Mentor and lead the Regulatory Affairs team. Manage regulatory responses and ensure effective team communication. Support QMS optimization and continuous improvement. Requirements and Skills: Minimum 10 years of experience in regulatory affairs within Medical Technology Extensive knowledge of EU regulations and experience negotiating with regulatory agencies and Notified Bodies. Proven leadership abilities, including team management experience, mentorship, and strong decision-making skills. Strategic thinking and the ability to thrive in a dynamic environment. Diploma and experience to act as Deputy PRRC. Fluency in English Good level of French language preferred.    Who Are Adaptive Life Science? Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally. We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.   Why Apply With Us? Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including: Expert advice on your CV and cover letter Guidance on salary expectations Personalized interview preparation Connections to exclusive job opportunities Assistance in negotiating the best possible offers 50% of the CVs we send to clients are accepted Accepted or declined, either way we will provide you with feedback We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs. Who Do Adaptive Work With? We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence. If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.   dominika.wyrwinska@adaptivelifescience.com #LI-DW1

Senior Regulatory Affairs Officer   Location: On-site in Geneva, Switzerland  Join a dynamic team specializing in the design and manufacturing of hyaluronic acid-based dermal fillers. As a Senior Regulatory Affairs Officer, you will be integral to shaping regulatory strategies for our innovative product range, managing regulatory submissions, and ensuring compliance with FDA requirements. You will coordinate responses to FDA inquiries, review product labeling, and participate in audits and inspections.  Key Responsibilities: Develop and implement regulatory strategies within cross-functional teams. Manage regulatory submissions (e.g., IDEs, PMAs) and ensure compliance with FDA requirements. Coordinate responses to FDA inquiries and review product labeling. Participate in audits and inspections to ensure regulatory compliance. Maintain and update regulatory databases and SOPs. Requirements: +6  years of experience in the medical device industry. Proficient in quality standards (ISO 13485) and regulations (21 CFR Part 820, MDR 2017/745). Strong analytical and critical thinking skills. Ability to manage multiple projects and prioritize effectively. Fluent in English and good level of French. Who Are Adaptive Life Science? Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally. We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.   Why Apply With Us? Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including: Expert advice on your CV and cover letter Guidance on salary expectations Personalized interview preparation Connections to exclusive job opportunities Assistance in negotiating the best possible offers 50% of the CVs we send to clients are accepted Accepted or declined, either way we will provide you with feedback We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs. Who Do Adaptive Work With? We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence. If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.   dominika.wyrwinska@adaptivelifescience.com #LI-DW1

Regulatory Affairs Specialist Are you an experienced Regulatory Affairs professional interested in Artificial Intelligence? We are currently supporting a client dedicated to advancing patient well-being through innovative AI technologies in radiology. The company operates 100% remotely and is now looking for a Regulatory Affairs Specialist to support their team with outstanding product quality and continuous regulatory compliance, breaking the last barrier before go-to-market. Your tasks: Ensuring product quality and continuous regulatory compliance. Support with market expansion. Report to Chief Medical Officer. Engage in product development by consulting on regulatory matters and managing risks. Shape process landscape and train employees to achieve operational excellence. What is required: Full proficiency in Business English and German. Excellent written and verbal communication skills. Experience with regulatory affairs (MDR and ISO 13485) IT skills and ability to thrive in a dynamic, fully remote environment. Experience in MedTech / SaaS / startup environment is an advantage. If you have any questions or you are interested in other roles within MedTech, please contact Dominika Wyrwinska at  dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Remote  

Head of Global Regulatory Affairs   Are you an experienced Regulatory Affairs professional who is passionate about utilizing AI to make a global impact in healthcare? Our Berlin-based client, an innovator in AI-driven diagnostic solutions, is currently looking for a Global Head of Regulatory Affairs. This role offers home office flexibility and the chance to lead a global team as they expand into international markets, including the US. You would oversee compliance, lead two employees, coordinate teams in India and Egypt, and support market access initiatives.   Your tasks:  Design and monitor processes according to ISO 13485 Lead the regulatory development of certified, AI-based medical devices Expand their software to new international markets, including the USA Oversee risk management in accordance with ISO 14971 Support the product team throughout the product lifecycle, and liaise with government agencies to uphold safety and effectiveness. Collaborate on data protection and IT security issues. Your Profile Experience with ISO 13485 for medical devices, preferably in SaMD. Knowledge of MDR, IEC 62304, ISO 14971, etc. +5 years of experience in Regulatory Affairs within medical technology Strong sense of responsibility and organization Excellent communication skills in English and German What is offered: A dynamic, results-oriented work environment with flexible office/home options. Opportunities for skill development through conferences, workshops, and seminars. Regular team events to enhance corporate culture and solidarity. If you're ready to pioneer the future of AI in healthcare, apply now! If you have any questions regarding the position, please contact: Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Remote

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  

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 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

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