At a Glance
- Tasks: Guide medical devices from development to market launch while ensuring regulatory compliance.
- Company: Join a leading biotech company with a global presence and a commitment to innovation.
- Benefits: Receive a competitive salary, 21 days holiday, and be part of a Living Wage Employer.
- Other info: Enjoy a modern office space and a culture that values diversity and inclusion.
- Why this job: Make a real impact in the biotech field and work in a dynamic, collaborative environment.
- Qualifications: 2+ years in regulatory affairs with experience in medical devices and ISO 13485.
The predicted salary is between 30000 - 40000 € per year.
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.
- 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...
Regulatory Affairs Officer in London employer: Abbexa Ltd
Abbexa is an exceptional employer located in Bar Hill, Cambridge, offering a vibrant work culture that fosters collaboration and innovation in the biotech sector. With a commitment to diversity and inclusion, employees benefit from a supportive environment, competitive salaries including the Living Wage, and opportunities for professional growth within a leading company dedicated to regulatory excellence in medical devices. Join us to be part of a dynamic team where your contributions will directly impact product development and compliance on a global scale.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Officer in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and IVDR requirements. We recommend practising common interview questions and scenarios related to regulatory compliance to show you’re the right fit for the role.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest checking out our website for openings at Abbexa, where you can find roles that truly excite you!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the position. We believe it’s a great way to keep yourself top of mind for the hiring team.
We think you need these skills to ace Regulatory Affairs Officer in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Officer role. Highlight your experience with ISO 13485 and any relevant regulatory frameworks. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background makes you a great fit for our team. Keep it engaging and relevant to the job description.
Showcase Your Attention to Detail:In regulatory affairs, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to present their best work right from the start!
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s straightforward and ensures your application goes directly to us. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Abbexa Ltd
✨Know Your Regulations
Make sure you brush up on the EU IVDR conformity assessment process and CE marking, especially if you've worked with ELISA products. Being able to discuss these frameworks confidently will show that you're not just familiar but also passionate about regulatory affairs.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've developed or maintained ISO 13485-compliant Quality Management Systems. Highlight how you’ve managed regulatory submissions and audits, as this will demonstrate your hands-on experience in a regulated environment.
✨Be Ready for Technical Questions
Expect questions about the technical documentation and compliance processes. Brush up on your knowledge of chemical regulations like REACH and CLP, and be prepared to discuss how you would ensure compliance across the product lifecycle.
✨Demonstrate Team Collaboration
Since this role involves working cross-functionally, think of examples where you've successfully collaborated with other teams. Emphasise your communication skills and how you’ve ensured that regulatory requirements were met throughout the organisation.
