- Regulatory & Clinical Affairs Lead
- Location: Primarily on-site, Watford area (UK)
- Salary: Up to £65,000
- Contract Type: Permanent
- Business Type: Small, growing medical device organisation
Cpl Life Sciences is collaborating with a growing medical device company that is seeking an experienced Regulatory & Clinical Affairs Lead to take ownership of all regulatory and clinical documentation activities within a dynamic small‑business environment. This is a pivotal role with significant autonomy, responsible for shaping clinical and regulatory strategy, driving compliant processes, and leading end‑to‑end Clinical Evaluation Reports (CERs) across the product portfolio.
This position is ideal for someone who thrives in a hands-on, influential role where clinical expertise and regulatory knowledge intersect. You will be the go‑to specialist for all matters relating to clinical and regulatory compliance.
Key Responsibilities
Clinical Evaluation & Evidence Development
- Lead the full lifecycle of Clinical Evaluation Report (CER) creation, updates, and maintenance in line with EU MDR and relevant international standards.
- Conduct critical appraisal of clinical data, literature reviews, and post-market surveillance to support robust clinical evidence generation.
- Influence internal teams on clinical strategy and ensure clinical claims remain compliant and evidence-backed.
- Oversee post-market clinical follow-up (PMCF) planning and execution.
Regulatory Affairs Leadership
- Act as the primary regulatory point of contact for the business, providing expert guidance across product development, changes, and lifecycle management.
- Prepare, manage, and maintain regulatory submissions and technical documentation (e.g., Technical Files, Annex XIV requirements).
- Ensure ongoing compliance with global regulatory frameworks, with a focus on EU MDR.
- Monitor regulatory changes and communicate their impact to the wider business.
Cross-Functional Influence
- Partner closely with R&D, Quality, manufacturing, and leadership teams to embed strong clinical and regulatory practices.
- Support audits, inspections, and external certification activities.
- Represent the business in discussions with Notified Bodies and external regulatory authorities when required.
Strategic Input & Continuous Improvement
- Develop and enhance clinical and regulatory processes, templates, and documentation systems.
- Play a key role in shaping the long‑term regulatory and clinical roadmap for the company.
Skills & Experience Required
- Significant experience working within Clinical Affairs, Regulatory Affairs, or a hybrid role in the medical device or healthcare technology sector.
- Proven track record of leading end‑to‑end Clinical Evaluation Reports (CERs) under MDR.
- Strong understanding of regulatory requirements for medical devices (EU MDR essential; UK and US desirable).
- Experience working in small or fast‑paced organisations where autonomy and cross-functional collaboration are key.
- Excellent written communication skills with the ability to interpret, analyse, and present clinical evidence clearly.
- Ability to influence stakeholders at all levels and lead regulatory/clinical decision-making.
What’s on Offer
- Permanent opportunity to lead the entire Clinical & Regulatory function.
- High autonomy and visibility within a small, growing organisation.
- Salary up to £65,000, depending on experience.
- On-site role in the Watford area, offering close collaboration with the wider technical and leadership teams.
This role does not offer sponsorship so you must hold the full right to work in the UK.
For more information please contact lucy.kirkaldy@cpl.com
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