SVP Regulatory Affairs & Quality Assurance

Help us transform healthcare

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.

Learn more about us at www.precisionlife.com

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

  • Supplier qualification programs

• Manage supplier and manufacturing partner audits and oversight

• Maintain product technical documentation including:

  • Design History Files

  • Technical Files

  • Device Master Records

  • Performance Evaluation documentation

• Lead external audits and inspections, including interactions with:

  • Notified Bodies

  • 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

  • Good Machine Learning Practice (GMLP)

• 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

• Support governance of genomic and other special category data

• Embed quality and regulatory thinking across Product, Engineering, Clinical and Commercial functions

• Support biopharma partnerships, companion diagnostic (CDx) programs and due diligence activities

• Advise 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

  • Diagnostics

  • 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
  
  

Desirable

• PhD or Regulatory Affairs Certification (RAC)

• Experience with AI/ML-enabled medical products

• Experience with FDA 510(k) and/or De Novo submissions

• Companion Diagnostics (CDx) experience

• 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

• Build a high-performing RA/QA function integrated within the product development lifecycle
  
  

What We Offer

• Competitive executive-level salary

• 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

• The 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:

https://precisionlife.com/privacy-policy

If you have questions regarding data protection, please contact: GDPR@precisionlife.com