
Posted 4 days ago
Executive
MerilExecutive
Perks & benefits
Family VisaHealth Insurance
Requirements
Bachelor's, Master's, or PhD in scientific discipline, 1-3 years CER writing experience, Knowledge of Med Dev 2.7/1, rev 4, 1-3 years clinical, regulatory, quality or engineering experience, Advanced Microsoft Office skills
Skills
Medical DevicesRegulatory Affairs
About the role
Responsibilities
- Develop and write clinical evaluation reports (CER) for pre- and post-market medical devices.
- Organize and evaluate large amounts of scientific, clinical, and medical data to create coherent and convincing CERs.
- Manage the CER writing process by planning, identifying, appraising, and analyzing clinical data.
- Ensure quality compliance by following internal and external SOPs, Work Instructions, and templates.
- Acquire, interpret, and analyze clinical data from trials, literature, and clinical experiences.
- Communicate scientific content in a clear and concise manner.
- Assist with other clinical, regulatory, quality, and engineering projects as assigned.
Requirements
- Bachelor's, Master's, or PhD in a scientific discipline.
- 1-3 years of experience specifically in CER writing.
- Solid knowledge of Med Dev 2.7/1, rev 4.
- 1-3 years of professional experience in clinical, regulatory, quality, or engineering roles.
- Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Strong written and oral communication skills with the ability to manage projects and prioritize tasks.
- Ability to read, analyze, and implement complex regulations and standards.
Benefits
- Enhanced skills and expertise through professional development.
- Opportunities for knowledge transfer and a broadened professional network.
- A diverse and inclusive work environment.
- Improved morale and increased productivity within a global team.
About the Company
Founded in 2006, Meril is a global medical device company dedicated to the innovation, design, and development of state-of-the-art healthcare solutions. We aim to alleviate human suffering and improve quality of life through advanced R&D in vascular intervention, orthopaedics, in-vitro diagnostics, endo-surgery, and ENT products. Headquartered in India with a workforce of over 4,000, Meril conducts business in more than 100 countries.
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Meril · Pardi
