At a Glance
- 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.
- Other info: Be part of a collaborative environment with excellent career growth opportunities.
- 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.
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
Arevna is an exceptional employer located in the heart of Cambridge, offering a dynamic work environment that fosters innovation and collaboration within the life sciences sector. Employees benefit from a competitive salary package, generous annual leave, and a strong focus on professional development, including mentorship opportunities for junior talent. With a commitment to regulatory excellence and a culture that values teamwork, Arevna provides a meaningful and rewarding career path for those passionate about advancing healthcare technologies.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager (IVD) in Cambridge
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Arevna. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Arevna.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Arevna. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Arevna is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Affairs Manager (IVD) in Cambridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Arevna!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Arevna that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Arevna!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Arevna, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Arevna
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Arevna that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Arevna’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
