Regulatory Affairs Specialist

Regulatory Affairs Specialist job description. Responsible for regulatory affairs with Technical Files, or equivalent in an R&D or quality position. Must have knowledge of European/International and US regulations and standards.

Requirements

• Knowledge of European/International and US regulations and standards
• Experience in preparing and content of technical files and design dossiers
• Experience with preparation, review, and/or auditing of medical device DHFs, Risk Management files, and/or DMR’s

Benefits

• Paid vacations
• Holidays
• Personal days
• Medical, Dental and Vision insurance
• 401K retirement savings plan
• Life Insurance
• Disability Insurance