PrecisionLife
SVP Regulatory Affairs & Quality Assurance
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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 & outcomes, predict patients’ drug responses, and reduce the cost of delivering effective care.
We’re a precision medicine company with global ambition and partnerships with some of the largest international healthcare companies and research institutes. We’re headquartered near Oxford, UK, with offices in London, Copenhagen, Warsaw, and Boston, MA. To learn more, visit: https://precisionlife.com/
The Role
The SVP RA/QA will be responsible for ensuring PrecisionLife’s Mechanostic products meet all IVD and software/AI/SaMD related regulatory and quality requirements for their approval, marketing and lawful commercialization. The role will lead the implementation of ISO13485 and management of the related Quality Management System, the regulatory strategy across EU (IVDR), UK (UKCA/MHRA) and US (FDA, CLIA, LDT, SaMD) markets, and the regulatory and quality interfaces with biopharma partners on companion diagnostic (CDx) programmes (in the future).
The role will also support the company’s existing information security and privacy management certifications (ISO 27001 and ISO 27701), extending these to cover the company’s handling of personal genomic, clinical and payment data.
This is a hands-on leadership role in a scaling AI precision medicine company. The successful candidate will balance strategic regulatory direction with implementation and operational delivery — building the function, owning elements of external audits and submissions, and embedding compliance across product, R&D, clinical and commercial teams.
Responsibilities
Key Responsibilities — Quality
- Own, maintain and continuously improve PrecisionLife’s Quality Management System to EN ISO 13485:2016, US FDA QMSR (21 CFR 820 transition), CLIA and applicable LDT requirements.
- Act as Management Representative in accordance with EN ISO 13485:2016.
- Participate in the Management Review process; establish and report QMS performance metrics for the executive team and Board.
- Own document control, training records, CAPA, nonconformance, change control, internal audit and supplier audit programmes for product related certifications and regulatory bodies.
- Direct selection process, audit and monitoring of external suppliers and manufacturing partners; ensure design, development and production processes meet applicable standards.
- Maintain the Design History File / Device Master Record / Technical File / Performance Evaluation File for each device/product.
- Lead preparation for, and host, external audits (EU Notified Body, FDA, MHRA, UKAS, biopharma partner audits).
- Operationalise risk management to ISO 14971 (with ISO/TR 24971) across the product lifecycle.
- Support and enhance the company’s existing ISO 27001 (Information Security Management) and ISO 27701 (Privacy Information Management) certification related activities, including risk assessments, SoA, document control implementation.
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.
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Key Responsibilities — Data Governance & Cross-Functional
- Partner with the DPO and ISO 27001 & ISO 27701 Committee Management Team on Data Security and GDPR compliance for genomic and special-category data, including DPIAs, international transfers and data subject rights.
- Embed quality and regulatory thinking into Product, R&D, Clinical and Commercial functions; 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.
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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.
PrecisionLife reserves the right to amend, withdraw or close this vacancy at any time without notice. We may close the application process earlier than the advertised closing date if a sufficient number of suitable applications are received. Early application is therefore encouraged.
The information contained in this advertisement is intended to provide an overview of the role and does not form part of any contract of employment. The duties, responsibilities and requirements described may be amended from time to time to meet business needs.
Any offer of employment will be subject to satisfactory completion of pre-employment checks.
Data Privacy
By submitting an application, you acknowledge that your personal data
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