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- Tasks: Join our team to manage global product license registrations and regulatory submissions.
- Company: Be part of a growing IVD manufacturer on the outskirts of Edinburgh.
- Benefits: Enjoy a competitive salary of £35,000 to £40,000 plus benefits and potential relocation support.
- Why this job: Make an impact in regulatory affairs while developing your skills in a supportive environment.
- Qualifications: A relevant degree or experience in regulatory affairs, especially in medical devices or biotech.
- Other info: This role requires full right to work in the UK; no sponsorship available.
The predicted salary is between 28000 - 46000 £ 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 lucy.kirkaldy@cpl.com
Please note this position does not offer sponsorship, however could offer relocation support for the right candidate.
Cpl Life Sciences | Regulatory Affairs Officer employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Cpl Life Sciences | Regulatory Affairs Officer
✨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 and expertise during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in the medical device or IVD sectors. Engaging with industry groups or attending relevant conferences can provide valuable insights and connections that may lead to job opportunities.
✨Tip Number 3
Stay updated on the latest changes in regulatory requirements and guidance documents. Being knowledgeable about current trends and updates will position you as a proactive candidate who is ready to contribute from day one.
✨Tip Number 4
Prepare to discuss your previous experiences with regulatory submissions, particularly any successful BLA or 510(k) applications you've worked on. Highlighting specific examples will showcase your hands-on experience and problem-solving skills in this area.
We think you need these skills to ace Cpl Life Sciences | Regulatory Affairs Officer
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and requirements for the Regulatory Affairs Officer position. Tailor your application to highlight relevant experience in regulatory documentation and compliance.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in the medical device or IVD industry, particularly any work related to regulatory submissions like BLA, 510(k), or CE marking. Use specific examples to demonstrate your expertise.
Showcase Your Skills: Clearly outline your skills in preparing regulatory reports and filings. Mention any experience you have with ISO13485 and other relevant regulations, as well as your ability to liaise with regulatory authorities.
Proofread Your Application: Before submitting your application, carefully proofread your documents to ensure there are no errors. A well-presented application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulations
Make sure you are well-versed in the specific regulations mentioned in the job description, such as ISO13485, IVD 2017/746, and FDA CFRs. Being able to discuss these regulations confidently will show your expertise and readiness for the role.
✨Prepare Regulatory Documentation Examples
Bring examples of regulatory documentation you have prepared in the past, such as BLA or 510(k) submissions. This will demonstrate your hands-on experience and ability to manage product license registrations effectively.
✨Showcase Your Communication Skills
Since the role involves liaising with internal and external parties, be prepared to discuss how you have successfully communicated complex regulatory information in previous roles. Highlight any experience you have in making presentations to regulators.
✨Stay Updated on Industry Changes
Demonstrate your commitment to continuous learning by discussing recent changes in regulatory requirements or guidance documents. This shows that you are proactive and dedicated to maintaining compliance in a fast-evolving field.
