Clinical Evaluation Report Manager

Olympus Corporation of the Americas • Upper Saucon, PA

121d • $104,061 - $145,685

About The Position

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 and meet timelines according to projects and requirements from regulations and laws. 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 ensuring that clinical evaluation reporting activities are conducted in accordance with regulatory and company standard meeting all timeframes and targets with the highest quality. 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. The job is conducted in line with our Core Values which are: patient focus, integrity, innovation, impact, and empathy.

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.

Responsibilities

• Creation, update and management of Clinical Evaluation Reports (CER), Clinical evaluation plans (CEP), Post-Market Clinical Follow Up Plans (PMCF Plan), Post-Market Clinical Follow Up Reports (PMCF reports), and SSCP (Summary of safety and clinical performance).
• Coordination and review of the CEP, CER, PMCF plan, PMCF report, and SSCP documents as generated by external supplier(s) or Clinical Evaluation Report Writers.
• 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 Product Management, Risk Management, R&D 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 Product or Marketing Management and clinical affairs.
• Prepare and support audits at OSTA side.
• Report directly to Regional Lead CER.
• Other duties as assigned.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Master's degree