Regulatory Analyst/Writer (Medical Device)

Industry Medical Devices
Discipline Regulatory Affairs
Location Remote - Home Office
Reports To Senior Analyst/Medical Writer
Nerac Analysts:
The Nerac Life Sciences/Medical Device Team works with medical device companies worldwide to
support their regulatory approval/recertification and monitors the on-going safety and efficacy of their
marketed products. The Regulatory Analyst/Writer will be responsible for providing regulatory support
during and after product regulatory approval.
Key Responsibilities:

• Review device documentation and draft reports
• Perform literature research and provide analysis
• Actively pursue continual learning and job-related development
• Communicate with clients in a professional manner

Required Education/Experience/Characteristics:

• Proven ability to multitask and adhere to timelines
• Advanced searching skills (Embase, PubMed, etc.)
• Demonstrated scientific or clinical writing skills
• Proven ability to work in a dynamic team environment
• Ability to review data and provide analysis in a clear and concise manner
• Excellent Microsoft Office skills (Word, Excel, Outlook)
• Experience reading, writing, and/or analyzing clinical or scientific literature
• Undergraduate or advanced degree in biomedical or health sciences

Preferred Skills and Knowledge:

• Experience creating Clinical Evaluation or Literature Reports for Medical Device submissions (US,

EU, China, Japan, Canada)

• Ability to work with globally located team members
• Good client service skills
• Strong analytical skills, both qualitative and quantitative
• Knowledge of medical device regulations and guidance
• Exceptional organizational skills plus keen attention to detail
• Creativity/originality in finding the right solutions for clients
• Deep intellectual curiosity about industry trends and emerging technologies
• Entrepreneurial, enthusiastic, collegial, and collaborative approach to work
• Medical writing experience

A writing sample will be required upon request.
For more information please go to:
https://www.nerac.com/career-opportunities/
To contact us directly: [email protected]