Chief Executive Officer
A leading provider of quality Sleep, Sleep Diagnostic, Respiratory and Cardiac Products
Senior Regulatory Affairs SpecialistHybrid - Sarasota, FL
The Senior Regulatory Affairs (RA) Specialist assesses product changes for reportability to appropriate regulatory agencies. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
- Prepare and maintain regulatory submissions, maintain 510k product registrations.
- Approve design/manufacturing changes. Analyze product changes for impact to current regulatory filings
- Maintain current standards list. Identify and lead projects to comply with latest standards (FDA expectation)
- Regulatory Intelligence: Monitor regulatory environment (FDA), Provide regulatory environment update in Management Reviews
- Primary point of contact for FDA interaction (questions/responses). Participate in FDA inspection as needed.
- Recall administration
- Participate in/lead internal audits
- If plan to market in other geographies, stay current on regulatory requirements. Lead CE mark requirement definition/implementation
- Support maintaining a cGMP compliant Quality Management System to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, cGMP, (MDD 93/42/EEC, MDR 2017/745,) and ISO 13485 regulatory requirements.
- Develop relevant regulatory procedures and work instructions as necessary.
- Lead audit readiness initiative. Investigate and document issues relating to the product, process, or Quality System relevant to the regulatory compliance.
- Bachelor’s degree in engineering or life science discipline, or equivalent experience
- Minimum 7 years of RA experience in the medical device industry
- Strong understanding of ISO 13485 and FDA 21 CFR Part 820 requirements
- Strong understanding of statistical techniques
- Understanding of regulatory requirements for software submission a plus
- Regulatory Affairs Certification (RAC) highly preferred
- Excellent communication and documentation skills
- Strong organization and attention to detail skills