- Location: New Hampshire, United States
- Type: Contract
- Job ID: 10476
- Work Setting: On-Site
- Posted: July 20, 2026
- Closing Date: December 31, 2026
- Tax Status: W2
Consultant, Regulatory & Quality Lead, Medical Devices
Summary
Our client, a growing medical device firm, has engaged GForce to provide a Regulatory & Quality Lead to serve as the technical lead across multiple programs while continuing to develop into a management and leadership role. This opportunity is ideal for an experienced Senior Regulatory Affairs/Quality Assurance Specialist or Senior Regulatory Consultant who has demonstrated technical excellence, has begun leading projects or mentoring junior staff, and is ready to expand into leadership, project management, and strategic consulting. The successful candidate will work directly with leadership, progressively assuming greater responsibility for leading engagements, mentoring junior regulatory professionals, and contributing to the continued growth of the company.
Responsibilities
Requirements
Nice to Have
Terms & Start
Summary
Our client, a growing medical device firm, has engaged GForce to provide a Regulatory & Quality Lead to serve as the technical lead across multiple programs while continuing to develop into a management and leadership role. This opportunity is ideal for an experienced Senior Regulatory Affairs/Quality Assurance Specialist or Senior Regulatory Consultant who has demonstrated technical excellence, has begun leading projects or mentoring junior staff, and is ready to expand into leadership, project management, and strategic consulting. The successful candidate will work directly with leadership, progressively assuming greater responsibility for leading engagements, mentoring junior regulatory professionals, and contributing to the continued growth of the company.
Responsibilities
- Regulatory Strategy
- Lead or support regulatory strategy throughout the product lifecycle, including FDA pathways (510(k), De Novo, PMA, IDE, Breakthrough Devices) and global regulations (EU MDR, Health Canada, UK, Australia, and other international markets).
- Develop regulatory strategies that align compliance requirements with business objectives and commercialization goals.
- Quality Systems
- Lead and support Quality Management System activities, including FDA QMSR, ISO 13485, ISO 14971, Design Controls, CAPA, audits, supplier quality, complaint handling, post-market surveillance, and management reviews.
- Perform gap assessments and help implement scalable quality systems.
- Project Leadership
- Serve as the primary regulatory advisor for projects, leading technical discussions, developing regulatory roadmaps, managing project timelines, coordinating cross-functional teams, and supporting regulatory agency interactions.
- Deliver high-quality project outcomes while building strong client relationships.
- Mentorship & Business Development
- Mentor junior regulatory professionals through coaching, document review, and knowledge sharing.
- Support business growth through proposal development, presentations, technical scoping, conference participation, and development of new consulting services.
- Professional Development
- Stay current on evolving FDA and international regulations, industry standards, AI, Software as a Medical Device (SaMD), Digital Health, and emerging medical technologies.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or related technical discipline
- Advanced degree preferred
- 3–7 years of progressive Regulatory Affairs and Quality Assurance experience within the medical device industry
- Experience with FDA QMSR and EU MDR
Nice to Have
- Experience with Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), or Digital Health technologies is highly desirable
Terms & Start
- 6+ month contract, potential to convert to FT
- Remote
- Start at the end of August
Pay: 40-43/hr