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- Tasks: Lead global regulatory strategies and ensure product compliance across markets.
- Company: Dynamic company in the life sciences sector with a collaborative culture.
- Benefits: Competitive salary, hybrid work model, and opportunities for professional growth.
- Why this job: Shape regulatory strategy and influence product development in a high-impact role.
- Qualifications: Degree in life sciences and over 5 years of regulatory experience required.
- Other info: Join a supportive team and make a real difference in global health.
The predicted salary is between 36000 - 60000 £ per year.
We are seeking an experienced Regulatory Affairs Manager to lead global regulatory activities across a product portfolio and ensure the products remain safe, effective, and compliant for worldwide markets. This is an exciting opportunity for a proactive regulatory professional to shape regulatory strategy, influence product development, and play a key leadership role within the RA department.
What you'll be doing:
- Lead regulatory strategies and submissions for new and updated products.
- Act as the regulatory lead and SME for product development projects, providing solution-focused guidance.
- Review and approve technical documentation, risk management files, performance evaluation evidence and submission materials.
- Manage global registrations, regulatory submissions, and interactions with authorities, authorised representatives, distributors, and external partners.
- Oversee post-market surveillance, vigilance reporting, and safety officer responsibilities.
- Ensure regulatory compliance of product labelling, promotional materials, and commercial documentation.
- Maintain accurate regulatory records, documentation systems, and databases.
- Provide expert interpretation of global regulations and support conformity to evolving standards.
- Contribute to leadership, training, and development within the RA team.
- Act as the Person Responsible for Regulatory Compliance (PRRC) under EU IVDR.
Essential Criteria:
- Degree-level education or equivalent in a life science or related discipline.
- >5 years of experience in IVD and/or medical device regulation (preferably EU-related).
- Recognisable qualification in Regulatory Affairs (e.g., RAPS, TOPRA) and evidence of ongoing CPD.
- Strong experience working within an ISO 13485 Quality Management System.
- Ability to independently manage multiple projects, department initiatives, and day-to-day regulatory tasks.
Desirable Criteria:
- Expertise in IVD regulatory frameworks, including 21 CFR Part 820 (QSR/QMSR).
- Experience in post-market surveillance, vigilance, and product recall activities.
- Proven experience interacting with competent authorities, global regulators, and notified bodies.
Why join us?
- High-impact strategic role with global regulatory responsibility.
- Opportunity to influence product development and organisational compliance.
- Supportive, collaborative working environment.
- Competitive salary and benefits package.
Regulatory Affairs Manager in Cambridge employer: Russell Taylor Group Ltd
Contact Detail:
Russell Taylor Group Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, attend industry events, and join relevant online groups. 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 brushing up on your knowledge of global regulations and compliance standards. Be ready to discuss how you've tackled challenges in previous roles and how you can bring that expertise to the table.
✨Tip Number 3
Showcase your leadership skills! Highlight any experience you have in training or mentoring others in regulatory affairs. Employers love to see candidates who can contribute to team development and foster a collaborative environment.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're genuinely interested in joining our team and making an impact in regulatory affairs.
We think you need these skills to ace Regulatory Affairs Manager 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 regulation, and don’t forget to mention any relevant qualifications like RAPS or TOPRA.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Talk about your leadership experience and how you’ve influenced product development in the past.
Showcase Your Regulatory Knowledge: In your application, demonstrate your understanding of global regulations and compliance standards. Mention specific frameworks you’ve worked with, like ISO 13485, to show you know your stuff!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It’s the best way for us to receive your application and get you on our radar quickly!
How to prepare for a job interview at Russell Taylor Group Ltd
✨Know Your Regulations
Make sure you brush up on the latest IVD and medical device regulations, especially those relevant to the EU. Being able to discuss specific regulations like 21 CFR Part 820 will show that you're not just familiar with the basics but are also well-versed in the nuances of regulatory affairs.
✨Showcase Your Leadership Skills
As a Regulatory Affairs Manager, you'll be expected to lead projects and guide teams. Prepare examples from your past experiences where you've successfully led regulatory strategies or influenced product development. This will demonstrate your capability to take charge and make impactful decisions.
✨Prepare for Technical Questions
Expect to be asked about your experience with technical documentation and risk management files. Be ready to discuss how you've reviewed and approved these materials in previous roles. Having specific examples at hand will help you articulate your expertise effectively.
✨Engage with the Interviewers
Don't forget that interviews are a two-way street! Prepare thoughtful questions about the company's regulatory strategies and how they align with global compliance. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
