Manager Clinical Affairs

Aspire Life Sciences Search; Berlin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Aspire Life Sciences Search client, a Berlin-based innovative medical device company, seeks a Clinical Affairs Manager to lead clinical evaluation, regulatory evidence generation and PMCF activities. You will collaborate with Medical Affairs, R&D and Regulatory teams to shape evidence strategies and engage physicians and KOLs across international markets.

The role requires a medicine/biomedical sciences degree and hands-on CER experience, with fluency in German and English.

Qualifications

• Degree in Medicine, Biomedical Sciences, Life Sciences or related field.
• Experience in Clinical Affairs, Clinical Evaluation, Medical Affairs or Regulatory Affairs in medical devices.
• Solid understanding of EU MDR and clinical evidence requirements.
• Hands-on CER preparation/maintenance experience.
• Experience with PMS/PMCF and systematic literature reviews.
• Knowledge of regulatory investigations and study design in regulated devices.
• Strong scientific writing and stakeholder management.

Responsibilities

• Own EU MDR-compliant clinical evaluation and regulatory evidence generation.
• Prepare and maintain CERs and CEPs.
• Develop PMS and PMCF activities and documentation.
• Conduct literature reviews and evidence assessments.
• Plan and support clinical studies to generate robust evidence.
• Review proposed investigations for regulatory/clinical relevance.
• Engage with KOLs, physicians, and scientific partners.
• Organize medical conferences, events, and education programs.
• Deliver clinical training and educational materials to healthcare professionals.
• Gather clinical insights to support product development and strategy.
• Support international expansion through scientific partnerships.
• Collaborate with Regulatory, Quality, R&D, Medical Affairs and senior management.

Skills

Stakeholder management

Scientific writing

Regulatory understanding

Communication skills

Education

Medicine / Biomedical Sciences / Life Sciences degree

Job description

Our Client is an innovative medical device company based in Berlin, developing advanced technologies for the treatment of cardiovascular and inflammation-related conditions.

As they expand their clinical and international activities, they are seeking an experienced Clinical Affairs Manager to take ownership of clinical evaluation, regulatory evidence generation and post-market clinical activities, while supporting Medical Affairs, scientific partnerships and physician engagement.

The role

• Taking ownership of EU MDR-compliant clinical evaluation and ensuring the clinical evidence supporting the company's medical devices meets regulatory requirements.
• Preparing, maintaining and updating Clinical Evaluation Reports (CER) and supporting Clinical Evaluation Plans (CEP).
• Developing and maintaining Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities and documentation.
• Conducting systematic literature reviews, scientific evidence assessments and state-of-the-art evaluations.
• Supporting the planning and development of clinical studies, ensuring study designs generate appropriate clinical evidence in accordance with EU MDR.
• Reviewing proposed clinical investigations from a regulatory and clinical evidence perspective.
• Building and maintaining relationships with Key Opinion Leaders (KOLs), physicians, clinical investigators and scientific partners.
• Supporting the organisation of medical conferences, scientific events, clinical workshops and physician education programmes.
• Developing and delivering clinical training, scientific presentations and educational materials for healthcare professionals and external partners.
• Gathering clinical insights and feedback from physicians and clinical partners to support product development and clinical strategy.
• Supporting international expansion through scientific communication, clinical partnerships and engagement with new markets.
• Working closely with Regulatory Affairs, Quality, R&D, Medical Affairs and senior management to align clinical evidence, regulatory requirements and product development.

Required experience

• Degree in Medicine, Biomedical Sciences, Life Sciences, Natural Sciences or a related scientific discipline.
• Professional experience in Clinical Affairs, Clinical Evaluation, Clinical Research, Medical Affairs or Regulatory Affairs within the medical device industry.
• Strong understanding of EU MDR (Regulation EU 2017/745) and the regulatory requirements for clinical evaluation and clinical evidence.
• Hands‑on experience preparing or maintaining Clinical Evaluation Reports (CER).
• Experience with PMS, PMCF, clinical evidence generation and systematic literature reviews.
• Understanding of clinical investigation requirements, study design and clinical research activities within a regulated medical device environment.
• Experience working with physicians, clinical investigators, KOLs or scientific partners is highly desirable.
• Experience developing scientific communications, clinical training materials or medical education activities would be advantageous.
• Background in cardiovascular medical devices, cardiology, immunology, inflammation or related therapeutic areas would be highly desirable.
• Strong scientific writing, analytical, communication and stakeholder management skills.
• Ability to work independently, take ownership of clinical activities and collaborate across multidisciplinary teams.
• Fluent German and English, both written and spoken.
• Based in Berlin or willing to work on‑site in Berlin-Steglitz