Regulatory Affairs Officer

This is an exciting and challenging opportunity to join a leading biotech company with branches in Cambridge (UK), Houston (US) and Leiden (NL), providing products and services globally. We are looking for a Regulatory Affairs Officer to join our dynamic team in Bar Hill, Cambridge. This is a fantastic opportunity for a regulatory professional with strong experience in Medical Devices regulatory frameworks. In this varied role, you'll assist the team with guiding products from inception and development through to market launch and beyond. The successful candidate will be the Person Responsible for Regulatory Compliance (PRRC) for Abbexa.

Role & Responsibilities

• Develop, implement, and maintain ISO 13485-compliant Quality Management System (QMS) to meet IVDR requirements for UK/EU product development and manufacturing.
• Create, manage, and update regulatory and quality documentation, including procedures, guidelines, and cross-functional work instructions, providing subject-matter expertise to support regulatory strategy.
• Act as the Person Responsible for Regulatory Compliance (PRRC), fulfilling all obligations defined under IVDR Article 15 (e.g., oversight of technical documentation, conformity assessment, PMS, vigilance).
• Monitor evolving regulatory requirements, evaluate their business impact, and implement solutions to ensure continued compliance.
• Prepare, manage, and coordinate regulatory submissions (e.g., Technical Files, CE marking, UKCA, FDA submissions, MHRA notifications) for internal and external stakeholders.
• Support internal and external audits, including notified body and regulatory authority inspections.
• Ensure compliance with chemical and safety regulations (e.g., REACH, CLP), maintaining up-to-date Safety Data Sheets and product regulatory documentation.
• Work cross-functionally to ensure regulatory requirements are met across the product lifecycle and throughout the wider organisation.

Desired Skills & Experience

• Proven experience with the EU IVDR conformity assessment process and CE marking (preferably ELISA products).
• Experience working within an ISO 13485-regulated environment.
• Excellent attention to detail, communication, and organisational skills.
• Ability to manage multiple regulatory projects effectively.
• Minimum 2+ years’ experience in a regulated medical device or IVD environment.
• Knowledge of US FDA regulatory pathways, including 510(k)/PMA submissions.
• Understanding of REACH/CLP and other chemical regulatory frameworks.
• Advantageous: Experience in a senior or lead role within Regulatory Affairs.

This role is 100% office based which is a large open-plan, newly refurbished modern space. Abbexa is an equal opportunities employer. We are committed to maintaining a diverse and inclusive workforce and are dedicated to promoting a culture of inclusion, respect and fairness and providing a positive environment for collaboration. We value diversity and are dedicated to treating all our colleagues and applicants fairly and with respect. Abbexa has been accredited as a Living Wage Employer. The Living Wage commitment means everyone working at Abbexa will receive the Living Wage which is higher than the government minimum wage. The package will include 21 days holiday (plus Bank Holidays) and the day off for your Birthday. It also includes access to a comprehensive pension scheme and healthcare benefits. This is a full-time, permanent position. The hours are Monday – Friday, 8am – 5pm (one hour lunch).