At a Glance
- 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 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 is essential; medical device experience preferred.
- 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
Please note this position does not offer sponsorship, however could offer relocation support for the right candidate.
Regulatory Affairs Officer, Diagnostics 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, Diagnostics
✨Tip Number 1
Familiarize yourself with the specific regulatory frameworks mentioned in the job description, such as ISO13485 and FDA regulations. Understanding these standards will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in IVD or medical devices. 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. This knowledge will not only prepare you for potential interview questions but also show that you are proactive and dedicated to continuous learning in your field.
✨Tip Number 4
Prepare to discuss your previous experiences with regulatory submissions, particularly any successful BLA or 510(k) applications you've worked on. Being able to articulate your hands-on experience will set you apart from other candidates.
We think you need these skills to ace Regulatory Affairs Officer, Diagnostics
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 showcases your passion for regulatory affairs and your understanding of the industry. Mention specific experiences that align with the job's requirements and how you can contribute to the company's success.
Highlight Relevant Skills: In your application, make sure to highlight skills that are crucial for the role, such as attention to detail, communication skills, and the ability to work collaboratively with internal and external stakeholders. Provide examples of how you've successfully used these skills in past roles.
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 how you have applied them in previous roles.
✨Showcase Your Documentation Skills
Since the role involves preparing regulatory documentation, be ready to provide examples of dossiers or submissions you've worked on. Highlight your attention to detail and ability to compile complex information clearly and coherently.
✨Demonstrate Your Communication Skills
This position requires liaising with various stakeholders. Prepare to discuss how you've effectively communicated with internal teams and external regulators in the past, including any presentations or negotiations you've conducted.
✨Stay Updated on Regulatory Changes
Regulatory affairs is a constantly evolving field. Show that you keep up with new regulations and industry standards. You might want to mention any recent changes you've learned about and how they could impact the company.