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.

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 MDR

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

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

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

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

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

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

• Support design changes, ensuring proper impact assessment and regulatory compliance

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

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

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

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

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

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

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

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

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

• Demonstrated experience managing Design History Files and leading design control processes

• Firsthand experience of regulatory authority audits

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

• Ability to influence design decisions through data-driven insights

• Familiarity with eQMS systems

Preferred Attributes

• 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

What's on Offer

• 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

Immediate 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.

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