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- Tasks: Manage product licence registrations and prepare regulatory documentation for global compliance.
- Company: Established IVD manufacturer with a growing Regulatory Affairs Department.
- Benefits: Competitive salary, relocation support, and opportunities for professional growth.
- Why this job: Join a dynamic 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: Work in a collaborative environment on the outskirts of Edinburgh.
The predicted salary is between 30000 - 40000 £ per year.
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; 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 regulatory dossiers and/or supporting documentation. The department will also manage the maintenance of such registrations/licences once granted.
Responsibilities
- Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 CFR, 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 submissions 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 CFR, 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 contributions to regulatory applications are produced to an appropriate standard for submission.
- Develop product labeling 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 labeling.
- 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 CFR, BLA, 510(k), CMDR.
- Provide 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.
- Experience 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 in Edinburgh employer: Jobster
Contact Detail:
Jobster Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer in Edinburgh
✨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 relevant regulations and guidelines. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest using our website to find roles that excite you and match your skills in regulatory affairs.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. We believe it’s a great way to keep yourself top of mind for hiring managers.
We think you need these skills to ace Regulatory Affairs Officer in Edinburgh
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 team. Be sure to mention any specific experiences that relate to the responsibilities listed in the job description.
Showcase Your Knowledge: Demonstrate your understanding of the regulatory landscape, especially regarding IVDs and medical devices. Mention any relevant regulations or guidelines you’re familiar with, as this shows us you’re serious about the role and ready to hit the ground running.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy!
How to prepare for a job interview at Jobster
✨Know Your Regulations
Make sure you brush up on the key regulations relevant to the role, like ISO13485 and FDA 21 CFR. Being able to discuss these confidently will show that you’re not just familiar with the requirements but also passionate about regulatory affairs.
✨Prepare Your Documentation Examples
Have specific examples of regulatory submissions you've worked on ready to share. Whether it’s a BLA or a 510(k), being able to walk through your process and the challenges you faced will demonstrate your hands-on experience.
✨Show Your Team Spirit
This role involves liaising with various teams, so be prepared to discuss how you’ve collaborated in the past. Highlight any experiences where you’ve advised colleagues or coordinated efforts for successful submissions.
✨Stay Updated on Industry Changes
Regulatory affairs is always evolving, so make sure you’re aware of the latest updates in regulations and guidance documents. Mentioning recent changes during your interview can show that you’re proactive and committed to continuous learning.
