Regulatory Manager

Job Description – QA/RA Manager (UK & EU)

Location: Remote (UK or EU based)

Reports to: Head of Operations / CEO

Function: Quality Assurance & Regulatory Affairs

About the Company

We are an innovative women’s health company focused on developing and commercialising medical devices that empower people to manage menstrual and reproductive health. Our first product is a wearable pain relief device that delivers safe, non-invasive therapy, and we are scaling operations across the UK and EU markets.

Role Overview

The QA/RA Manager will lead quality assurance and regulatory affairs across the UK and EU, ensuring compliance with MDR (EU 2017/745), UKCA, ISO 13485, and other applicable standards. This individual will be responsible for maintaining the Quality Management System (QMS), driving regulatory submissions, managing audits, and supporting product lifecycle compliance from design through post-market surveillance.

This is a hands-on role suited to someone with experience in small, fast-growing medical device companies, who can combine strategic oversight with operational execution.

Key Responsibilities

Regulatory Affairs

• Develop and execute regulatory strategies for CE marking (MDR) and UKCA certification.
• Prepare and maintain Technical Documentation, Clinical Evaluation Reports, and regulatory submissions.
• Act as primary contact with UK Notified/Approved Bodies and regulatory authorities.
• Monitor evolving regulatory requirements across UK/EU and update internal processes accordingly.
• Support international expansion by assessing additional regulatory pathways.

Quality Assurance

• Maintain and improve the ISO 13485-compliant Quality Management System (QMS).
• Manage internal audits, external audits, and supplier quality oversight.
• Develop risk management documentation in line with ISO 14971.
• Oversee complaint handling, vigilance reporting, and post-market surveillance activities.
• Ensure documentation control, training, and quality records are current and audit-ready.

Cross-functional support

• Partner with product development, clinical, and commercial teams to ensure compliance from R&D through to market.
• Provide QA/RA input during product development, labelling, advertising, and promotional material reviews.
• Train and mentor internal staff on regulatory and quality compliance requirements.

Candidate Profile

Essential:

• 5+ years of experience in QA/RA within the medical device sector.
• Strong knowledge of EU MDR (2017/745), UKCA requirements, ISO 13485, and ISO 14971.
• Proven track record of CE marking submissions and regulatory approvals.
• Experience in managing audits with Notified/Approved Bodies.
• Excellent documentation and technical writing skills.
• Ability to work independently in a fast-paced, international start-up environment.

Desirable:

• Experience with active therapeutic devices, wearables, or women’s health technologies.
• Knowledge of FDA 510(k) submissions (Class II devices).
• Experience in building or scaling QMS in a start-up environment.
• Familiarity with risk-benefit analysis in pain relief or reproductive health devices.