SVP Regulatory Affairs & Quality Assurance

PrecisionLife is helping transform the delivery of healthcare by building the next generation of precision medicine solutions and Mechanostics ® tests to improve disease detection, patient triage.

Key Responsibilities — Regulatory:

• Define and execute global regulatory strategy across EU IVDR, UK (UKCA / MHRA), US (FDA 510(k), De Novo, PMA, CLIA, LDT) and other priority markets.
• Act as, or designate and oversee, the Person Responsible for Regulatory Compliance (PRRC) under IVDR Article 15.
• Lead product related regulatory submissions, certificate renewals, technical documentation and responses to deficiencies; own Notified Body relationship and capacity planning.
• Develop and own the regulatory pathway for AI/ML-enabled SaMD products, including FDA AI/ML guidance, Good Machine Learning Practice (GMLP), Predetermined Change Control Plans, IMDRF SaMD framework and the EU AI Act (high-risk medical AI).
• Own post-market surveillance regulatory oversight, PMS plans, PSURs, vigilance, FSCA and incident reporting under IVDR and FDA MDR.
• Own software lifecycle compliance oversight: IEC 62304 and IEC 82304.
• Own labelling, IFU, packaging and storage regulatory requirements across markets.
• Work with the Company Senior Management Team to provide clinical study regulatory oversight: Performance Evaluation Plan, scientific validity, analytical performance, clinical performance, PER, PMPF.
• Support and collaborate with the team on topics of cybersecurity regulatory requirements: IEC 81001-5-1, FDA premarket cybersecurity guidance, SBOM.
• Provide strategic regulatory input across the product lifecycle to the CPO, CEO, CTO, CBO and Board; brief and present to regulators and Notified Bodies.
• Monitor evolving regulation across all target markets and translate into actionable internal guidance.

Key Responsibilities — Data Governance:

• Act as the trusted regulatory voice in early product decisions.
• Represent RA/QA in biopharma partner due diligence, CDx co-development agreements and regulatory interactions.
• Other duties as required from time to time by the Management team.

Key Requirements:

• Degree in a life science, engineering, computer science or related discipline.
• PhD or RAC (Regulatory Affairs Certification) preferred but not essential where equivalent senior operational experience is demonstrated.
• ISO 13485 accreditation and audit experience.
• Working knowledge of ISO 14971, IEC 62304, IEC 82304, ISO 15189 and IEC 81001-5-1.
• Working knowledge of ISO 27001 and ISO 27701.

Key Attributes:

• Minimum 10 years’ RA/QA experience in IVD, medical device or diagnostics, including at least 3 years in a leadership role.
• Demonstrated success obtaining regulatory approval for SaMD-based IVDs under IVDR (CE mark) and US frameworks (CLIA, LDT, and ideally 510(k) or De Novo).
• Experience meeting the criteria of, or directly supporting, an IVDR Article 15 PRRC.
• Experience implementing and maintaining a QMS in a scale-up or start-up environment — not a large-corporate-only background.
• Experience with AI/ML-enabled medical software is strongly preferred.
• Strong internal and external audit experience (hosting and conducting).
• Prior medical device manufacturing or contract-manufacturer oversight experience.
• Excellent communication skills, both verbal and written, including for submissions, technical documentation, regulator correspondence.
• Pragmatic, commercially aware, comfortable challenging at executive level.
• Able to work effectively to tight deadlines within a collaborative team-orientated environment using sound judgement in decision-making.
• Organised and detail-oriented, being able to prioritise and perform multiple tasks effectively and concurrently.

Year-One Success Measures (indicative):

• Establish ISO 13485 certification but scaled appropriately for current product mix.
• LDT route(s) operational to support PrecisionLife’s first consumer product launches in the US and EU — CLIA/CAP-certified lab partner qualified, analytical and clinical validation documentation in place, regulatory file complete and EU/MHRA lab strategy.
• First consumer launch product(s) shipped with full RA/QA sign-off on labelling, IFU, claims, consent flows, complaint handling and customer-facing materials.
• FDA LDT Final Rule phase-out compliance plan in place and on schedule; pre-submission engagement initiated for products on a path to 510(k) / De Novo.
• Support completion of consumer-scale privacy and data flows validated under GDPR, ISO 27701 and applicable US state genomic privacy requirements.
• PMS, vigilance, complaint handling and CAPA systems operational at consumer scale with measurable KPIs.
• RA/QA function appropriately resourced and embedded in product development governance.

What We Offer:

• Competitive salary with performance related bonuses.
• Stock Options (subject to qualifying).
• Company pension scheme.
• Life Assurance/Death in Service Insurance (subject to qualifying).
• Private Healthcare Scheme (subject to qualifying).
• Flexible-Hybrid working pattern model to allow for flexibly between remote and office working.
• 25 days annual leave (pro rata) (increasing to equivalent of 28 days hols/annum on completion 3 years of service).
• Access to substantial number of courses and training events.
• Excellent career development opportunities in a fast-growing international organisation.

Right to Work:

Employment is subject to verification of identity, qualifications and the legal right to work in the United Kingdom. Successful candidates will be required to provide appropriate documentation as part of our pre-employment screening process.

Data Privacy:

By submitting an application, you acknowledge that your personal data will be processed for recruitment purposes in accordance with our Privacy Policy and applicable data protection legislation, including the UK GDPR, EU GDPR and the Data Protection Act 2018.