Director Regulatory and Quality

We are currently supporting a growing orthopaedic medical device company based in New York that is looking to appoint a Director of Regulatory Affairs & Quality. This is a key, hands-on leadership role where you’ll take ownership of both regulatory strategy and quality systems, helping to bring innovative orthopaedic products to market while ensuring full compliance.This is an ideal opportunity for someone who enjoys operating in a small, agile environment where you can make a real impact and work closely with senior leadership.Key ResponsibilitiesRegulatory AffairsLead regulatory strategy and submissions for orthopaedic devicesPrepare and submit 510(k)s and manage interactions with the FDAProvide regulatory guidance across the full product lifecycle, including design and post-market activitiesAssess regulatory impact of design changes and new product developmentQuality & ComplianceOwn and maintain the Quality Management System in line with FDA 21 CFR Part 820 and ISO 13485Lead audits and ensure ongoing inspection readinessOversee CAPA, complaints, nonconformances, and supplier qualityDrive continuous improvement across quality processesLeadership & CollaborationPartner closely with R&D, Operations, and Commercial teamsAct as one of the regulatory and quality SMEs for the organisationSupport and mentor junior team members as the function growsWhat We’re Looking For10+ years of experience in Regulatory Affairs and/or Quality within medical devicesStrong experience with orthopaedic products (highly preferred)Proven track record with 510(k) submissionsDeep knowledge of FDA regulations and ISO 13485Comfortable in a hands-on role within a small company environmentStrong communication skills and ability to influence cross-functional teams