Valtera Group · 1 day ago
Regulatory Affairs Consultant
United States
Part-time
Remote
Senior Level, Lead/Staff
10+ years expValtera Group is a confidential, innovation-driven medical device company focused on advancing a novel collagen-based biomaterial through late-stage clinical development. They are seeking a senior Regulatory Affairs Consultant to provide expert FDA guidance on market entry strategy for complex medical devices, ensuring regulatory readiness and alignment with FDA expectations.
Staffing & Recruiting
No H1B
Hiring Manager
Fleur Waterston
Responsibilities
Define and advise on the most appropriate FDA regulatory pathway (e.g., 510(k), De Novo, PMA) for a collagen-based medical device
Provide expert review and refinement of core FDA submission documentation, ensuring technical and regulatory robustness
Advise on device classification, predicate strategy, and regulatory justification for novel biomaterials
Lead preparation for FDA pre-submission (Q-Sub) interactions, including briefing packages and question strategy
Conduct regulatory gap assessments across clinical, non-clinical, manufacturing, and quality documentation
Provide guidance on labelling, indications for use, claims, and risk documentation
Advise on post-market surveillance and US compliance obligations where relevant
Deliver practical, actionable guidance suitable for a lean, fast-moving development team
Qualification
Required
10+ years of hands-on Regulatory Affairs experience in US medical devices
Direct involvement in successful FDA submissions (510(k) required; De Novo or PMA strongly preferred)
Demonstrated experience with novel, non-traditional, or biologically derived medical devices
Deep working knowledge of FDA expectations for biocompatibility, clinical evidence, and risk management
Experience supporting early-stage, scale-up, or first-in-class medical technologies
Ability to operate independently in a consultative, advisory capacity rather than a full operational role
Comfortable engaging with scientific, clinical, quality, and executive stakeholders
Company
Valtera Group
Valtera partners with life sciences and applied technology companies at critical stages of growth.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase