Workforce Manager
SimplePractice
Clinical Evaluation Report Manager
Olympus Corporation of the Americas
full-time
Posted on:
Location Type: Hybrid
Location: 🇺🇸 United States
Visit company websiteSalary
💰 $104,061 - $145,685 per year
Job Level
Mid-LevelSenior
About the role
- 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.
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.
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**
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical Evaluation Reports (CER)Clinical Evaluation Plans (CEP)Post-Market Clinical Follow Up Plans (PMCF Plan)Post-Market Clinical Follow Up Reports (PMCF reports)Summary of Safety and Clinical Performance (SSCP)Systematic analysis of clinical evidenceLiterature researchInterpretation and analysis of scientific literatureKnowledge of applicable laws and regulationsRisk Management (ISO 14971)
Soft skills
Highly self-organizedEfficient working styleStrong communication skillsTeam-player
Certifications
Master's degree in health sciencePhD in health science
