QA/RA Manager

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.

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  Lead and maintain Design Control processes in compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR

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  Ensure robust implementation of design inputs, outputs, verification, and validation activities

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  Oversee Design History File (DHF) completeness, accuracy, and audit readiness

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  Drive risk management activities in accordance with ISO 14971, including FMEA and hazard analysis

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  Ensure usability engineering and human factors requirements are fully integrated into product development

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  Support test methods, validation, and reporting for biocompatibility, sterilisation, packaging integrity, ageing, and bench testing

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  Partner with R&D to embed quality into product design from concept through to commercialisation

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  Support design changes, ensuring proper impact assessment and regulatory compliance

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  Develop, implement, and maintain the Quality Management System (QMS)

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  Oversee CAPA, deviations, and non-conformance processes related to design and development

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  Lead internal and external audits, including design-focused regulatory inspections

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  Provide regulatory guidance and support preparation of documentation for FDA and CE marking submissions

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  Mentor and provide training to QA/RA team members on design controls, regulatory requirements, and quality practices

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  Collaborate cross-functionally with R&D, Clinical, and Product Management teams

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  Bachelor's Degree in Engineering, Life Sciences, or a related field

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  10+ years' experience in Quality Assurance, Regulatory Affairs, or Design Assurance within a medical device environment

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  Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971

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  Demonstrated experience managing Design History Files and leading design control processes

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  Firsthand experience of regulatory authority audits

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  Strong track record in team building, stakeholder management, and cross-functional collaboration

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  Ability to influence design decisions through data-driven insights

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  Familiarity with eQMS systems

• Experience hosting and leading FDA and other regulatory authority audits

• Background in early-stage or start-up medical device companies

• Comfortable working at pace with a high degree of autonomy

• Strong attention to detail with excellent written and verbal communication skills

• Motivated by meaningful work with direct patient impact

• Competitive contractor day rate based on experience

• The chance to make a genuine impact at a critical stage of product development

• Collaborative, purpose-driven team culture

• A role where your expertise directly shapes patient outcomes

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future relevant vacancies.

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