SVP Regulatory Affairs & Quality Assurance
Location: Oxfordshire, UK (Hybrid) Contract type: Full-time Permanent contract
Reporting to: Chief Product Officer (with direct access to CEO)
PrecisionLife is transforming healthcare by developing next-generation precision medicine solutions and Mechanostics® tests that improve disease detection, patient triage, treatment outcomes, and the prediction of drug responses while reducing healthcare costs.
We are an innovative precision medicine company with global ambitions and partnerships with leading healthcare organizations, pharmaceutical companies, and research institutions worldwide. Headquartered near Oxford, UK, we also operate from offices in London, Copenhagen, Warsaw, and Boston.
We are seeking an exceptional Senior Vice President of Regulatory Affairs & Quality Assurance (SVP RA/QA) to lead our global regulatory and quality strategy as we scale our AI-enabled precision medicine and diagnostics platform internationally.
This is a rare opportunity to join an ambitious growth-stage company and play a critical role in bringing innovative diagnostic and software-based healthcare products to patients across Europe, the UK, the US and beyond.
The Opportunity
As SVP Regulatory Affairs & Quality Assurance, you will lead the development and execution of PrecisionLife's regulatory and quality strategy across our portfolio of diagnostics, software and AI-enabled medical products.
You will be responsible for ensuring that our products meet applicable regulatory, quality, privacy and compliance requirements for approval, market access and commercialization. The role combines strategic leadership with hands‑on execution, requiring a leader who can build capability while actively driving submissions, audits, certifications and operational compliance.
You will lead implementation of ISO 13485 and the associated Quality Management System while overseeing regulatory pathways across:
European Union (IVDR)
United Kingdom (MHRA / UKCA)
United States (FDA, CLIA, LDT, SaMD)
You will also support and enhance PrecisionLife's ISO 27001 and ISO 27701 certifications, ensuring appropriate governance of sensitive genomic, clinical and personal data.
Key Responsibilities
Quality Leadership
Own, maintain and continuously improve the Quality Management System (QMS) aligned to:
EN ISO 13485:2016FDA QMSR (21 CFR 820 transition)
FDA QMSR (21 CFR 820 transition)
CLIA requirements
Applicable LDT regulations
Act as Management Representative under ISO 13485
Lead Management Reviews and establish executive-level quality metrics and reporting
Oversee:
CAPA
Non-conformance management
Change control
Training records
Internal audits
Manage supplier and manufacturing partner audits and oversight
Maintain product technical documentation including:
Design History Files
Technical Files
Device Master Records
Lead external audits and inspections, including interactions with:
FDA
MHRA
UKAS
Biopharma partners
Embed risk management practices aligned to ISO 14971
- Support ongoing ISO 27001 and ISO 27701 certification activities
Regulatory Leadership
Define and execute global regulatory strategy across EU, UK and US markets
Act as, or oversee, the Person Responsible for Regulatory Compliance (PRRC) in accordance with IVDR Article 15
Lead regulatory submissions, technical documentation and authority interactions
Own relationships with Notified Bodies and regulatory agencies
Develop regulatory pathways for AI/ML-enabled Software as a Medical Device (SaMD) products
Provide oversight for:
IVDR compliance
FDA pathways including 510(k), De Novo and PMA
CLIA and LDT frameworks
AI Act considerations
Lead post-market surveillance, vigilance reporting and incident management activities
Ensure compliance with:
IEC 62304
IEC 82304
Cybersecurity requirements
Labelling and IFU requirements across target markets
Provide regulatory leadership for clinical and performance evaluation activities
Data Governance & Business Partnership
Partner with the DPO and senior leadership on GDPR, privacy and information security initiatives
S upport governance of genomic and other special category data
Embed quality and regulatory thinking across Product, Engineering, Clinical and Commercial functions
S upport biopharma partnerships, companion diagnostic (CDx) programs and due diligence activities
A dvise the Executive Team and Board on evolving global regulatory requirements
What We're Looking For
Essential Qualifications & Experience
Degree in Life Sciences, Engineering, Computer Science or a related discipline
Minimum 10 years' Regulatory Affairs and Quality Assurance experience within:
IVD
Medical Device
Digital Health
Minimum 3 years in a senior leadership position
Demonstrable experience obtaining regulatory approvals under:
EU IVDR
UK regulatory frameworks
US CLIA/LDT frameworks
Extensive ISO 13485 implementation and audit experience
Strong experience hosting and managing external audits
Experience supporting or meeting IVDR Article 15 PRRC requirements
Experience building and maintaining quality systems in a start-up or scale-up environment
Excellent written and verbal communication skills
Technical Knowledge
Working knowledge of:
ISO 14971
IEC 62304
IEC 82304
ISO 15189
IEC 81001-5-1
ISO 27001
ISO 27701
PhD or Regulatory Affairs Certification (RAC)
Experience with AI/ML-enabled medical products
Experience with FDA 510(k) and/or De Novo submissions
Medical device manufacturing or contract manufacturing oversight experience
Personal Attributes
You will be:
Strategic yet hands-on
Commercially aware and pragmatic
Comfortable influencing at Executive and Board level
Organized and detail-oriented
Able to manage multiple priorities in a fast-paced environment
Collaborative and relationship-focused
Driven by quality, compliance and patient impact
What Success Looks Like in Year One
Establish and embed a fit-for-purpose ISO 13485-certified quality system
Support launch readiness for PrecisionLife's first consumer products in Europe and the US
Implement scalable post-market surveillance, vigilance and CAPA systems
Develop and execute regulatory pathways supporting future FDA submissions
Strengthen privacy, information security and data governance controls
B uild a high-performing RA/QA function integrated within the product development lifecycle
What We Offer
Performance-related bonus
Share option scheme (subject to eligibility)
Company pension scheme
Life assurance
Private healthcare (subject to eligibility)
Flexible hybrid working
25 days annual leave plus public holidays
Increased holiday entitlement with service
Professional development and training opportunities
T he opportunity to shape a fast-growing international precision medicine business
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.
Diversity, Equity & Inclusion
PrecisionLife is committed to building a diverse and inclusive workplace where everyone can thrive. We welcome applications from all qualified candidates regardless of age, disability, gender identity, gender expression, marital or civil partnership status, pregnancy or maternity, race, ethnicity, religion or belief, sex, sexual orientation, socio-economic background, or any other characteristic protected by applicable law.
We are committed to providing reasonable adjustments throughout the recruitment process and during employment.
Legal & Recruitment Disclaimer
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, which may include verification of identity, right to work, professional qualifications, employment history, references, regulatory status and, where appropriate and legally permissible, background screening.
Employment decisions are made on the basis of merit, qualifications and business need. PrecisionLife is committed to providing equal employment opportunities and does not discriminate on the grounds of any characteristic protected under applicable UK, EU or local employment legislation.
Candidates who require reasonable adjustments during any stage of the recruitment process are encouraged to inform us so appropriate support can be provided.
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.
For information on how we collect, use and protect your personal information, please view our Privacy Policy:
