SVP Regulatory Affairs & Quality Assurance

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)

Precision Life 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.

As SVP Regulatory Affairs & Quality Assurance, you will lead the development and execution of Precision Life'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 Precision Life's ISO 27001 and ISO 27701 certifications, ensuring appropriate governance of sensitive genomic, clinical and personal data.

Own, maintain and continuously improve the Quality Management System (QMS) aligned to:

EN ISO 13485:2016

FDA 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

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

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…