We are seeking an experienced and driven QA/RA Manager with a strong Design Assurance focus to join an exciting early-stage medical device company at a pivotal point in their growth journey. This is a rare opportunity to play a lead role in bringing a genuinely life-changing product to market — a catheter-based device designed to improve quality of life for patients in palliative care.Working within a passionate, fast-moving start-up environment, you'll take ownership of design control processes, drive regulatory compliance, and act as a key bridge between R&D and quality as the company accelerates from Phase 2 to Phase 4 over the next 18 months. If you thrive in an environment where your work truly matters and where no two days are the same, this is the role for you.Key Responsibilities include but are not limited to the following:Lead and maintain Design Control processes in compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDREnsure robust implementation of design inputs, outputs, verification, and validation activitiesOversee Design History File (DHF) completeness, accuracy, and audit readinessDrive risk management activities in accordance with ISO 14971, including FMEA and hazard analysisEnsure usability engineering and human factors requirements are fully integrated into product developmentSupport test methods, validation, and reporting for biocompatibility, sterilisation, packaging integrity, ageing, and bench testingPartner with R&D to embed quality into product design from concept through to commercialisationSupport design changes, ensuring proper impact assessment and regulatory complianceDevelop, implement, and maintain the Quality Management System (QMS)Oversee CAPA, deviations, and non-conformance processes related to design and developmentLead internal and external audits, including design-focused regulatory inspectionsProvide regulatory guidance and support preparation of documentation for FDA and CE marking submissionsMentor and provide training to QA/RA team members on design controls, regulatory requirements, and quality practicesCollaborate cross-functionally with R&D, Clinical, and Product Management teamsBachelor's Degree in Engineering, Life Sciences, or a related field10+ years' experience in Quality Assurance, Regulatory Affairs, or Design Assurance within a medical device environmentDeep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971Demonstrated experience managing Design History Files and leading design control processesFirsthand experience of regulatory authority auditsStrong track record in team building, stakeholder management, and cross-functional collaborationAbility to influence design decisions through data-driven insightsFamiliarity with eQMS systemsPreferred AttributesExperience hosting and leading FDA and other regulatory authority auditsBackground in early-stage or start-up medical device companiesComfortable working at pace with a high degree of autonomyStrong attention to detail with excellent written and verbal communication skillsMotivated by meaningful work with direct patient impactWhat's on OfferCompetitive contractor day rate based on experienceThe chance to make a genuine impact at a critical stage of product developmentCollaborative, purpose-driven team cultureA role where your expertise directly shapes patient outcomesImmediate interviews available for suitable candidates.Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future relevant vacancies.Pale Blue Dot® Recruitment – Experts in STEM Workforce Solutions
