Regulatory Affairs Specialist 3 (Addison, TX)
- 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.
- 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.
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