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.
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
Essential
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
Desired
* Knowledge of US FDA regulatory pathways, including 510(k)/PMA submissions
* Understanding of REACH/CLP and other chemical regulatory frameworks
* Bachelor’s degree in a relevant Life Science discipline
* Previous people‑management experience
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.
Our office is located in Bar Hill which offers a park, Tesco, coffee shop, barbers, clothes store and gyms, all within walking distance of the office.
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.
This is a full‑time, permanent position. The hours are Monday - Friday, 8am - 5pm (one hour lunch).
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.
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