Clinical Evaluation Manager (m/f/d)

OLYMPUS EUROPA SE & CO. KG; Hamburg; Hybrid; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

A leading global medical technology company is seeking a Clinical Evaluation Manager to oversee Clinical Evaluation Reports and ensure compliance with regulatory standards. The ideal candidate will hold a Master's degree or PhD, possess extensive MedTech experience, and demonstrate strong analytical and communication skills. The position offers flexible working arrangements and various employee benefits, including health support initiatives and a comprehensive pension scheme.

Leistungen

Flexible working hours

30 days of holidays per year

Modern office environment

Employee restaurant

Public transport ticket or free parking

Company sport groups

Employee Assistance Program

Comprehensive company pension scheme

Childcare services

Bike leasing

Qualifikationen

• Minimum of 3 years experience in CER creation in the MedTech industry.
• Strong knowledge of EU-MDR, MEDDEV 2.7.1 rev 4.
• Demonstrated organizational efficiency and communication skills.

Aufgaben

• Creation and management of Clinical Evaluation Reports (CERs).
• Coordination of CERs generated by external suppliers.
• Collaboration with stakeholders for clinical research support.

Kenntnisse

Knowledge of applicable laws

Analysis of scientific literature

Strong communication skills

Self-organization

Team player

Proficient in English

MS Office proficiency

Ausbildung

Master level degree or PhD in health science

Jobbeschreibung

Clinical Evaluation Manager (m/f/d)

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

Your Responsibilities

- Creation, update and management of CERs (Clinical Evaluation Reports) and/or SSCP (Summary of safety and clinical performance)
-Coordination and review of the CERs and/or SSCPs generated by external supplier(s)
-Systematic analysis of clinical evidence related to Olympus products or diagnostic/therapeutic procedures by literature research in relevant data bases (e.g. Pubmed, Embase, Cochrane)
-Close collaboration with various stakeholder in the regional organization (Product Management, Risk Management, R&D, Quality and Regulatory Affairs) to provide input on deliverables, clinical research and literature evidence and support product development process needs
-Planning and initiation of Post-market Clinical Follow-up activities together with Stakeholders
-Forecasting and planning of budget for regional CERs and belonging documents (internal & supplier)/ per fiscal year
-Prepare and support audits as well as other duties as assigned

Your qualification

- Master level degree or PhD in health science related field required
- Minimum of 3 years experience in CER creating required
- Minimum of 3 years business experience in MedTech Industry required
- Strong knowledge of applicable laws and regulations relevant to Clinical Evaluation, e.g. with EU-MDR, EU-MDD, MEDDEV 2.7.1 rev 4, MDCG Guidelines, ISO 14971 Risk Management
- Knowledge of interpretation and analysis of scientific literature
- Highly self-organized and efficient working style
- Demonstrated strong communication skills
- Team-player
- Proficient English both spoken and written
- Good knowledge of MS Office package
#LI-REMOTE #MIDSENIORLEVEL

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.

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 .

Further information:

Further information:

Your future inclusive workplace awaits

We value the diversity of individuals, perspectives, and lifestyles, and prioritize inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.

We warmly encourage all who wish to bring their talents to Olympus to apply.