Clinical Evaluation Manager (m/f/d)

Olympus Corporation; Hamburg; Hybrid; EUR 85.000 - 110.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

Remote work up to 40%

30 days of holidays per year

Modern office with inspiring working环境

Employee restaurant with live cooking

Public transport ticket subsidy

Company pension scheme

Bike leasing

Employee Assistance Program

Company medical officer and vaccines

Zusammenfassung

Olympus Corporation in Germany is seeking a senior Clinical Evaluation professional to author CERs/SSCPs, oversee external vendors, and drive evidence-based regulatory submissions.

The role involves PMCF planning, budget management, and collaboration with R&D, regulatory, and QA teams to ensure compliant, high-quality clinical data across the product lifecycle.

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 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 across functions.

Aufgaben

• Create, maintain, and manage CERs and SSCPs per regulatory requirements.
• Coordinate CERs and SSCPs prepared by external vendors for quality and compliance.
• Conduct systematic literature reviews and critically evaluate clinical evidence.
• Analyze and interpret literature to support regulatory submissions and post-market activities.
• Collaborate with Product Management, R&D, Risk, QA, and Regulatory Affairs.
• Plan and support PMCF activities with internal stakeholders.
• Manage forecasting and budgets for regional CER activities and related costs.
• Prepare and participate in audits and inspections.
• Mentor and supervise junior CER staff and interns.
• Contribute to continuous improvement initiatives.

Kenntnisse

CER authoring

Medtech regulations

Literature research

Medical writing

Regulatory affairs

Project management

Cross-functional collaboration

Ausbildung

Master's degree or PhD in Health Sciences/Life Sciences/Medicine

Tools

AI/LLM in clinical writing

Jobbeschreibung

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 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

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, visit www.olympus-europa.com and

follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA .