The Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. Relies on extensive experience and judgment to plan, create, develop and maintain materials needed for regulatory compliance. Uses technical knowledge to drive new product submissions, listings, and registration of medical devices. Trains and mentors lower-level specialists in regulatory activities.
Responsibilities:
Ensures all processes for the essential functions are documented in procedures.
Performs internal departmental audits and supports audits by third parties e.g., BSI, FDA and others, as required.
Initiates and maintains required establishment listings e.g., FDA and EU, including renewal or changes.
Develops company regulatory strategies and prioritization. Determines the best strategy to register new products in specific global markets.
Determines appropriate product testing to support registration activities. Ensures content accuracy and regulatory compliance for submission to regulatory agencies e.g., 510(k), PMA, MDR Technical Files/Design Dossiers, global registration applications, etc. Provides feedback / approval of compliant labeling e.g., IFUs, marketing materials, package labels, etc. Manages and leads responses to Regulatory Agency for submission deficiencies.
Maintains accurate international product registration, including renewal or changes, and certificates for foreign governments.
Provides direction/guidance as needed to other Regulatory Specialists.
Qualifications:- 5+ years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered)
- Evidence of applied knowledge of applicable FDA, ISO, MDR requirements, consensus standards and guidance documents.
- Ability to work under limited supervision with FDA, Notified Body, EU Authorized Representative, and other global regulatory agencies.
- Able to manage multiple projects simultaneously.
- Proven track record of strong teamwork, creatively strategic thinking.
- Ability to work well with others, support regulatory activities and mentor/train others.
- Excellent written and verbal communication skills. Master of Science in Regulatory Affairs preferred.
