Regulatory Affairs Specialist
On-site · Huntersville, North Carolina, United States
Huntersville, North Carolina, United StatesOn-siteFull TimeMid LevelBachelors DegreeUnknown
Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
Regulatory Affairs Specialist responsible for executing established regulatory strategy to achieve successful registration and lifecycle management of medical devices/pharma products, including regulatory submissions, labeling and promotional material review, FDA/GUDID compliance, ISO/FDA export requirements, and cross-functional collaboration with global teams to support post-market regulatory activities and license renewals.
Required Qualifications
- Bachelor’s Degree required
- At least 3 years of increasing Regulatory Affairs (Medical device and/or Pharma) experience
- Solid working knowledge of relevant domestic and global regulations and guidance
- History of successful interactions with global regulatory authorities
- Computer proficient to include web browser/internet search, MS Outlook, Word, Excel, and Power Point capabilities
- A combination of education and experience may be considered
- RAC certification is a plus
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