Regulatory & Compliance Specialist

Job Overview

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

Ideal Background

• Bachelor’s 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

Compensation & Benefits

• Based on experience and background
• Comprehensive benefits package including medical, dental, vision, life, disability, and 401(k) with employer match