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- Tasks: Lead regulatory strategies for innovative medical products and mentor a dynamic team.
- Company: Join Arevna, a pioneering life sciences organisation in Cambridge.
- Benefits: Enjoy a competitive salary, generous leave, and a non-contributory pension.
- Why this job: Make a real impact on product safety and compliance in the healthcare sector.
- Qualifications: Degree in life sciences and 5+ years in IVD or medical device regulatory affairs.
- Other info: Be part of a collaborative environment with excellent career growth opportunities.
The predicted salary is between 36000 - 60000 £ per year.
Arevna is partnering with a pioneering life sciences organisation to recruit a Regulatory Affairs Manager to join their Cambridge-based Regulatory & Medical Affairs function. This team ensures products are safe, effective, and globally compliant, enabling market access for cutting-edge technologies. You will take ownership of regulatory strategy and execution across the full product lifecycle, from pre-market submissions to post-market surveillance, vigilance, and recalls. You will also lead and mentor a team while partnering cross-functionally to shape regulatory pathways for innovative product development.
What you’ll be doing:
- Lead the design and delivery of regulatory strategies to support new product launches, updates, and market expansion.
- Serve as the regulatory lead and SME within cross-functional development teams, providing solution-focused guidance.
- Manage submissions, approvals, and regulatory interactions globally, ensuring timelines and compliance are met.
- Oversee post-market activities including vigilance, recalls, risk management, and product surveillance.
- Review and approve labelling, promotional materials, and technical documentation in line with international standards.
- Maintain compliance with ISO 13485 and other applicable frameworks, monitoring legislative changes and driving QMS alignment.
- Develop junior talent within the Regulatory Affairs function, building capability and ensuring best practice.
- Act as PRRC under IVDR (EU 2017/746) where designated.
What we’re looking for:
- Degree (or equivalent) in life sciences.
- 5+ years’ experience in IVD and/or medical device regulatory affairs, ideally with EU focus.
- Recognised qualification in Regulatory Affairs and evidence of CPD.
- Strong knowledge of ISO 13485, with the ability to manage multiple projects and priorities.
- Desirable: global IVD expertise including 21 CFR Part 820, experience in post-market activities, and direct engagement with Competent Authorities or notified bodies.
What’s on offer:
- Competitive salary package.
- 10% non-contributory pension.
- Group life assurance & income protection.
- 25 days annual leave plus UK bank holidays.
Regulatory Affairs Manager (IVD) in Cambridge employer: Arevna
Contact Detail:
Arevna Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager (IVD) in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory challenges and think about how your experience aligns with their needs. This will help you stand out as a candidate who’s genuinely interested.
✨Tip Number 3
Practice your pitch! Be ready to explain your regulatory experience and how it relates to the role. Use specific examples that showcase your skills in managing submissions and compliance – this is your time to shine!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace Regulatory Affairs Manager (IVD) in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience in IVD and medical device regulatory affairs, especially any EU-focused projects you've worked on. We want to see how your background aligns with 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 you can contribute to our team. Be sure to mention specific experiences that demonstrate your expertise in managing submissions and compliance.
Showcase Your Leadership Skills: Since this role involves leading and mentoring a team, make sure to highlight any leadership experiences you've had. We love to see examples of how you've developed junior talent or led cross-functional teams in your previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining our team at Arevna!
How to prepare for a job interview at Arevna
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of ISO 13485 and the IVDR regulations. Be ready to discuss how you've applied these in your previous roles, especially in IVD and medical device regulatory affairs. This will show that you're not just familiar with the theory but have practical experience too.
✨Showcase Your Leadership Skills
Since you'll be leading a team, prepare examples of how you've mentored junior talent or led cross-functional teams in the past. Highlight specific situations where your guidance made a difference in achieving regulatory compliance or successful product launches.
✨Prepare for Scenario Questions
Expect questions that ask how you'd handle specific regulatory challenges, like managing post-market activities or dealing with Competent Authorities. Think through potential scenarios and your approach to problem-solving, as this will demonstrate your strategic thinking and expertise.
✨Ask Insightful Questions
At the end of the interview, have some thoughtful questions ready about Arevna's regulatory strategies or their approach to market expansion. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
