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- Tasks: Lead a team in Regulatory Affairs, ensuring compliance and driving global strategies.
- Company: Join a growing IVD manufacturer on the outskirts of Edinburgh, Scotland.
- Benefits: Enjoy a competitive benefits package and flexible working options.
- Why this job: Be part of a dynamic team making an impact in diagnostics and medical devices.
- Qualifications: Requires a scientific degree and 7+ years of relevant experience.
- Other info: Relocation may be offered for the right candidate.
The predicted salary is between 48000 - 72000 £ per year.
A full-time, permanent position working 37.5 hours per week. An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. As a Regulatory leader, you will be responsible for leading the team and ensuring continuous improvements within the Regulatory function. Supporting and leading all areas of Regulatory Affairs from development through to post market surveillance, you will be driving global strategies and must be experienced within diagnostics/Medical Devices.
Responsibilities:
- Lead new registrations into new markets, EU, US, ROW
- Drive global RA and Quality strategies
- Ensure that all technical documentation is kept up to date
- Manage company wide compliance with ISO13485, IVDD, IVDR, FDA and Canadian Medical Device Regulations, and other global regulations
- Interpret complex legislation and deliver advice to various team members
- Assist with the implementation of the Company's Quality Policy
- Lead projects including product license applications
- Compile and submit initial registration/approval submissions in international markets
Key Requirements:
- A scientific degree and at least 7+ years of experience are needed, covering areas including but not limited to: US regulatory applications and EU CE marking (IVDD/IVDR)
- Managerial and leadership experience
- You must hold the full right to work in the UK; this role may offer relocation for the right candidate.
Seniority level: Director
Employment type: Full-time
Job function: Science, Quality Assurance, and Strategy/Planning
Industries: Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
Regulatory Affairs Team Lead employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Team Lead
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in IVDs and medical devices. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and regulations.
✨Tip Number 2
Familiarise yourself with the specific regulations mentioned in the job description, such as ISO13485, IVDD, and IVDR. Being able to discuss these regulations confidently during an interview will demonstrate your expertise and commitment to the role.
✨Tip Number 3
Prepare to showcase your leadership skills by gathering examples of how you've successfully led teams or projects in the past. Highlighting your managerial experience will be crucial, as this role requires strong leadership in regulatory affairs.
✨Tip Number 4
Research the company thoroughly, including their products and market presence. Understanding their specific challenges and opportunities in the regulatory landscape will allow you to tailor your discussions and show how you can contribute to their success.
We think you need these skills to ace Regulatory Affairs Team Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory affairs, particularly in diagnostics and medical devices. Emphasise your managerial and leadership skills, as well as your familiarity with regulations like ISO13485, IVDD, and FDA.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the role. Mention specific achievements in previous positions that demonstrate your ability to lead teams and drive compliance with global regulations.
Highlight Relevant Experience: In your application, clearly outline your experience with US regulatory applications and EU CE marking. Provide examples of how you have successfully managed projects related to product license applications and registration submissions.
Showcase Continuous Improvement Initiatives: Discuss any initiatives you have led that resulted in continuous improvements within regulatory functions. This could include streamlining processes or enhancing compliance measures, which are crucial for the role.
How to prepare for a job interview at Cpl Life Sciences
✨Showcase Your Regulatory Knowledge
Make sure to brush up on your knowledge of regulatory frameworks, especially those relevant to IVDs and medical devices. Be prepared to discuss specific regulations like ISO13485, IVDD, and IVDR, as well as your experience with US regulatory applications.
✨Demonstrate Leadership Skills
As a Regulatory Affairs Team Lead, you'll need to exhibit strong leadership qualities. Prepare examples of how you've successfully led teams or projects in the past, focusing on your ability to drive compliance and continuous improvement.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in regulatory affairs and how you navigated them, particularly in relation to market registrations and compliance issues.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready. Inquire about the company's future regulatory strategies or how they handle changes in legislation. This shows your genuine interest in the role and the organisation.
