Clinical Evaluation Manager (m/f/d)

OLYMPUS EUROPA SE & CO. KG; Hamburg; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

Remote work up to 60%

30 days of holidays per year

Modern office and inspiring workspace

Employee restaurant with live cooking

Zusammenfassung

Olympus Europa SE & Co. KG is seeking a Clinical Evaluation Manager to lead CER/SSCP creation, vendor oversight, and PMCF activities across a MedTech portfolio.

You will coordinate cross-functional teams, ensure regulatory compliance, and mentor junior CER staff. The role requires a master’s or PhD in health sciences, at least 3 years in CER authoring and MedTech experience, plus strong literature research, medical writing, and AI governance capabilities.

Qualifikationen

• Master's degree or PhD in Health Sciences, Life Sciences, Medicine, or 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 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 information.
• Excellent verbal and written communication skills, with the ability to engage stakeholders across functions.

Aufgaben

• Create, maintain, and manage CERs and SSCP documents.
• Coordinate CERs and SSCPs prepared by external vendors.
• Conduct systematic literature reviews using PubMed, Embase, Cochrane.
• Analyze and interpret scientific literature for regulatory submissions and post-market activities.
• Collaborate with Product Management, R&D, Risk Management, Quality Assurance, and Regulatory Affairs.
• Plan and support PMCF activities with internal stakeholders.
• Manage annual forecasting and budgeting for CER activities and supplier costs.
• Prepare and participate in audits and inspections.
• Mentor and supervise working students, interns, and junior CER Managers.
• Contribute to continuous improvement initiatives.

Kenntnisse

Literature research

Clinical evaluation

Regulatory knowledge

Project management

Stakeholder coordination

Medical writing

AI governance awareness

Ausbildung

Master's/PhD in Health Sciences

Jobbeschreibung

Clinical Evaluation Manager (m/f/d)

Olympus Europa SE & Co. KG (OEKG)Medical & Scientific Affairs

Your Responsibilities

• 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.

Your qualification

• 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.

Your benefits

• Flexible working hours, remote work possible (up to 60%)
• 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

About Olympus

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

For more information, visitwww.olympus-europa.com and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA .