Clinical Evaluation Report Manager

April 2

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Olympus Corporation of the Americas

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Olympus Corporation of the Americas is a company dedicated to developing and delivering advanced medical technology solutions aimed at enhancing healthcare throughout the patient pathway. Their mission, encapsulated in the philosophy 'True to Life', focuses on improving the standard of care to empower individuals to lead fulfilling lives. Olympus offers a range of medical systems and is also involved in educational programs to support clinical expertise and procedural skills enhancement.

5001 - 10000 employees

🧬 Biotechnology

📋 Description

• The Clinical Evaluation Manager/Senior Clinical Evaluation Report Writer reports directly to the Regional Lead, Clinical Evaluation Reporting, MSA. • The individual creates CERs in support of EU-MDR regulatory approval strategies across Olympus business unit portfolio. • The individuals have an in-depth knowledge of the EU-MDR 2017/745, EU-MDD 93/42 EEC, MEDDEV 2.7.1 rev 4, and ISO 14971 Risk Management. • The Clinical evaluation manager collaborates with cross-functional teams across Quality Management, Design Assurance, Research and Development, Marketing, Regulatory Affairs, Medical Safety, and within the broader Olympus organization, as appropriate.

🎯 Requirements

• Master level degree or PhD in health science related field required. • Minimum of 5 years of experience in CER creating required. • Minimum of 5 years of business experience in MedTech Industry required. • Highly self-organized and efficient working style – demonstrated strong communication skills – Team-player • Strong knowledge of applicable laws and regulations relevant to Clinical Evaluation, e.g. with EU-MDR, EU-MDD, MEDDEV 2.7.1 rev 4, ISO 14971 Risk Management, • Knowledge of interpretation and analysis of scientific literature • Proficient English both spoken and written • Good knowledge of MS Office package • Has a comfortable remote working environment. • Has a stable internet connection for effective productivity. • Disciplined to work toward tasks with limited guiding direction.

🏖️ Benefits

• Competitive salaries, annual bonus and 401(k)* with company match • Comprehensive medical, dental, vision coverage effective on start date • 24/7 Employee Assistance Program • Free live and on-demand Wellbeing Programs • Generous Paid Vacation and Sick Time • Paid Parental Leave and Adoption Assistance* • 12 Paid Holidays • On-Site Child Daycare, Café, Fitness Center**