(Remote Work) Regulatory Analyst/Writer, Medical Device – NERAC

Job Overview:

  • Job Title: Regulatory Analyst/Writer, Medical Device
  • Hiring Organization: NERAC
  • Company Website: https://www.nerac.com/
  • Remote Locations: United States
  • Job Type: Remote, Full-Time

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.

Job Responsibilities:

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

Job Requirements:

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

Preferred Skills and Knowledge:

  • Experience creating Clinical Evaluation or Literature Reports for Medical Device submissions (US,
  • EU, China, Japan, Canada)
  •  Knowledge of medical device regulations and guidance
  • Strong analytical skills, both qualitative and quantitative
  • Good client service skills
  • Medical writing experience
  • Deep intellectual curiosity about industry trends and emerging technologies
  • Creativity/originality in finding the right solutions for clients
  • Entrepreneurial, enthusiastic, collegial, and collaborative approach to work
  • Exceptional organizational skills plus keen attention to detail
  • Ability to work with globally located team members
  • A writing sample will be required upon request.

How To Apply:

For more information please go to:  https://www.nerac.com/career-opportunities/
To contact us directly: careers@nerac.com

More Information

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