Deine Aufgaben

- Create, maintain, and manage Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCP) documents in accordance with applicable regulatory requirements.
- Coordinate, review, and oversee CERs and SSCPs prepared by external vendors, ensuring quality, consistency, and compliance.
- Conduct systematic literature reviews and critically evaluate clinical evidence related to medical devices, products, and associated diagnostic or therapeutic procedures using databases such as PubMed, Embase, and Cochrane.
- Analyze and interpret scientific literature to support clinical evaluations, regulatory submissions, and post-market activities.
- Collaborate closely with cross-functional stakeholders, including Product Management, R&D, Risk Management, Quality Assurance, and Regulatory Affairs, to provide clinical evidence and support product lifecycle and development activities.
- Plan, initiate, and support Post-Market Clinical Follow-Up (PMCF) activities in partnership with internal stakeholders.
- Manage annual forecasting and budget planning for regional CER activities and related documentation, including external supplier costs.
- Prepare, support, and participate in internal and external audits and inspections.
- Mentor, train, and supervise working students, interns, and junior CER Managers, fostering expertise in literature research, clinical evidence assessment, and medical writing.
- Contribute to continuous improvement initiatives and provide support across the team as required.

Deine Qualifikationen

- Master's degree or PhD in Health Sciences, Life Sciences, Medicine, or a related field.
- Minimum of 3 years of experience authoring Clinical Evaluation Reports (CERs).
- Minimum of 3 years of experience within the Medical Device (MedTech) industry.
- Strong expertise in literature research, critical appraisal of scientific evidence, clinical data analysis, and medical writing.
- In-depth knowledge of relevant regulations and standards, including EU MDR, EU MDD, MEDDEV 2.7/1 Rev. 4, MDCG guidelines, and ISO 14971.
- Demonstrated ability to independently manage complex projects and deliver high-quality results within timelines.
- Strong analytical and problem-solving skills, with the ability to synthesize large volumes of complex and sometimes conflicting information.
- Excellent verbal and written communication skills, with the ability to engage and influence stakeholders across different functions and levels.
- Proven ability to build trust, drive accountability, and achieve results in a collaborative environment.
- Strong commitment to continuous learning, professional development, and knowledge sharing.
- Highly organized, self-motivated, and efficient working style with a proactive and team-oriented mindset.
- Experience working with AI/LLM-enabled technologies, including an understanding of their limitations, governance requirements, associated risks, and responsible use practices.

Deine Vorteile

- Flexible working hours, remote work possible (up to 40%)
- 30 days of holidays per year
- Modern office and an inspiring working environment
- Employee restaurant with live cooking and healthy food (subsidized)
- Public transport ticket (100 % subsidized) or free parking space
- Company sport groups and an inhouse company gym
- Employee Assistance Program to support your health, mental and emotional well-being
- A comprehensive company pension scheme
- Company medical officer and vaccination offers
- Childcare through our ‘Buttje&Deern’ partner
- Bike leasing

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