Regulatory & Compliance Specialist
Job in
Iowa, Calcasieu Parish, Louisiana, 70647, USA
Listed on 2026-01-17
Listing for:
Specialized Recruiting Group - Dubuque, IA
Full Time
position Listed on 2026-01-17
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
Specialized Recruiting Group is searching for candidates on behalf of a local manufacturing company for a Regulatory & Compliance Specialist. This opportunity is well-suited for a detail-oriented professional interested in quality, compliance, and regulated products within the medical device space.
Key Responsibilities- Support regulatory compliance with FDA, ISO, and applicable international standards
- Assist with licensing, registrations, permits, and regulatory submissions (including 510(k) support)
- Maintain regulatory documentation, files, and databases to ensure ongoing compliance
- Partner with Quality and Engineering teams to review product changes, labeling, IFUs, and technical documentation
- Monitor new and evolving regulations and communicate impacts to internal teams
- Participate in internal and external audits and support CAPA activities
- Assist with complaint reviews, post-market surveillance, and regulatory reporting
- Respond to customer, regulatory agency, and third-party information requests
- Bachelor3s degree in Engineering, Healthcare, Biomedical Science, Biology, Chemistry, or a related science field
- Experience in regulatory affairs, quality, or a regulated industry is helpful but not required
- Strong attention to detail and documentation skills
- Ability to collaborate cross-functionally and communicate effectively
- Preference for candidates with local ties or who currently live in the area
- Based on experience and background
- Comprehensive benefits package including medical, dental, vision, life, disability, and 401(k) with employer match
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