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- Tasks: Join our team to manage global product license registrations and regulatory submissions.
- Company: We're a growing IVD manufacturer based near Edinburgh, dedicated to innovation in healthcare.
- Benefits: Enjoy a competitive salary of £35,000 to £40,000 plus relocation support and other perks.
- Why this job: Be part of a dynamic team making a real impact in the medical device industry.
- Qualifications: A relevant degree or experience in regulatory affairs is essential; medical device experience preferred.
- Other info: This role requires on-site work three times a week; full right to work in the UK is mandatory.
The predicted salary is between 28000 - 42000 £ per year.
Job Title: Regulatory Affairs Officer
Job Type: Full-time, permanent position
Location: Outskirts of Edinburgh, Scotland, UK – 3x a week on site. (Relocation support can be offered for the right candidate, however you MUST have the full right to work in the UK)
Remuneration: £35,000 to £40,000 + benefits
An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. Responsible for managing product licence registration with the appropriate regulatory authorities on a worldwide basis. This includes the preparation of any regulatory dossiers and/or supporting documentation. In addition, the department will manage the maintenance of such registrations/licences once granted.:
Main responsibilities:
- Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Biologics License Applications (BLA), Medical Device Approvals (510(k)), Canadian Medical Device Regulations (CMDR) – Part 1 and other country requirements as appropriate.
- Prepare and compile regulatory documentation, coordinate and execute regulatory submission for countries including US, EU, Canada and any other territories as appropriate in compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) – Part 1 and other country requirements as appropriate.
- Advise staff and project team members on data and information required for successful license applications and coordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
- Develop product labelling regulatory requirements for products and for customer-contracted products including but not limited to package labels, product labels and instructions for use.
- Liaise with internal and external parties as required to support the development of product labelling.
- Contribute to the regulatory watch process by maintaining knowledge of new or updated regulatory requirements, guidance documents and industry standards.
- Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs) Biologics License Applications (BLA), Medical Device Approvals (510(k), Canadian Medical Device Regulations (CMDR).
- Providing support to the Department Leader of Regulatory Affairs with regard to planning and co-ordination of activities and with regard to training and supervision of other members of the Regulatory Affairs team and to ensure continuous development of junior staff to develop their capabilities.
Requirements:
- A relevant degree and/or relevant work experience in a regulatory affairs environment.
Experience in a medical device / IVD / biotech industry
- Specialist knowledge of vigilance processes for US, EU and other jurisdictions as appropriate (MDR, BPDR, MEDDEV 2.12, etc.)
- Previous experience preparing and submitting BLA, 510(k), PMA, CE mark, and technical files to other worldwide regulatory authorities.
- Experienced in meeting with, making presentations to, and negotiating with regulators.
- Ability to prepare coherent regulatory reports and filings.
For more information please reach out to
Please note this position does not offer sponsorship, however could offer relocation support for the right candidate.
Regulatory Affairs Officer, IVD's employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer, IVD's
✨Tip Number 1
Familiarize yourself with the specific regulatory frameworks mentioned in the job description, such as ISO13485 and FDA regulations. This knowledge will not only help you understand the role better but also demonstrate your commitment to the field during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with IVDs and medical devices. Attend industry conferences or webinars to make connections that could lead to valuable insights or referrals.
✨Tip Number 3
Stay updated on the latest changes in regulatory requirements and guidance documents relevant to IVDs. This will not only enhance your knowledge but also show potential employers that you are proactive and engaged in your professional development.
✨Tip Number 4
Prepare to discuss your previous experiences with regulatory submissions, particularly any successful BLA or 510(k) applications you've been involved in. Be ready to share specific examples of challenges you faced and how you overcame them.
We think you need these skills to ace Regulatory Affairs Officer, IVD's
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Affairs Officer position. Understand the key responsibilities and requirements, especially the specific regulations and standards mentioned, such as ISO13485 and FDA CFRs.
Tailor Your CV: Customize your CV to highlight relevant experience in regulatory affairs, particularly in the medical device or IVD sectors. Emphasize any previous work with regulatory submissions like BLA or 510(k) and your familiarity with international regulations.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background to the specific needs of the company. Mention your experience with regulatory documentation and your ability to liaise with regulatory authorities, showcasing your communication skills.
Highlight Continuous Learning: In your application, mention any ongoing education or training related to regulatory affairs. This could include certifications or workshops that demonstrate your commitment to staying updated on industry standards and regulations.
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulations
Make sure you are well-versed in the relevant regulations such as ISO13485, IVD 2017/746, and FDA CFRs. Be prepared to discuss how your experience aligns with these standards and any specific examples of regulatory submissions you've handled.
✨Showcase Your Experience
Highlight your previous experience in preparing and submitting regulatory documents like BLA, 510(k), and CE mark applications. Use specific examples to demonstrate your expertise and how it can benefit the company.
✨Demonstrate Communication Skills
Since the role involves liaising with internal and external parties, be ready to showcase your communication skills. Prepare to discuss how you've effectively communicated complex regulatory information to team members or regulators in the past.
✨Stay Updated on Regulatory Changes
Show your commitment to continuous learning by discussing how you keep up with changes in regulatory requirements and industry standards. Mention any resources or networks you utilize to stay informed.
