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- Tasks: Manage product licence registrations and prepare regulatory documentation for global compliance.
- Company: Established IVD manufacturer located on the outskirts of Edinburgh.
- Benefits: Relocation support available, competitive salary, and opportunities for professional growth.
- Why this job: Join a growing team and make a real impact in the medical device industry.
- Qualifications: Relevant degree or experience in regulatory affairs, especially in medical devices.
- Other info: Dynamic work environment with a focus on continuous development and teamwork.
The predicted salary is between 36000 - 60000 £ per year.
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)
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.
- 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.
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 Regulatory Affairs Officer
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO13485 and IVD regulations. We recommend practising common interview questions related to regulatory submissions so you can showcase your expertise confidently.
✨Tip Number 3
Don’t forget to tailor your approach! When applying through our website, make sure your application highlights your experience with BLA, 510(k), and other relevant submissions. We want to see how you fit into the role!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way. We suggest mentioning something specific from your conversation to remind them why you’re the perfect fit for their team.
We think you need these skills to ace Regulatory Affairs Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Officer role. Highlight your relevant experience in regulatory submissions and compliance with standards like ISO13485 and FDA regulations. We want to see how your background fits perfectly with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your skills can contribute to our growing team. Don’t forget to mention any specific experiences that relate to the job description.
Showcase Your Knowledge: We love candidates who stay updated on industry standards and regulations. In your application, mention any recent training or knowledge you have about IVD regulations, BLA submissions, or vigilance processes. This shows us you’re proactive and engaged!
Apply Through Our Website: To make sure your application gets the attention it deserves, apply directly through our website. It’s the best way for us to track your application and ensure it reaches the right people. Plus, we can’t wait to hear from you!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulations
Make sure you brush up on the key regulations mentioned in the job description, like ISO13485 and FDA 21 CFRs. Being able to discuss these confidently will show that you’re not just familiar with them but can apply them in real-world scenarios.
✨Prepare Your Documentation Examples
Have specific examples ready of regulatory documentation you've prepared or submissions you've coordinated. This could include BLA or 510(k) submissions. Sharing these experiences will demonstrate your hands-on knowledge and problem-solving skills.
✨Showcase Your Communication Skills
Since liaising with internal and external parties is crucial, be prepared to discuss how you've effectively communicated complex regulatory information in the past. Think of instances where you’ve had to negotiate or present to regulators.
✨Stay Updated on Regulatory Changes
Demonstrate your commitment to continuous learning by discussing recent changes in regulations or guidance documents. This shows that you’re proactive and dedicated to staying informed, which is vital in the ever-evolving field of regulatory affairs.
