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
- Remote Job Location United States
- Salary Offer to be discussed
- Experience Level Mid Level, Senior Level
- Education Level Associate Degree
- Working Hours to be arranged (full time based )
- Job Application Via Custom Application Page
