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- Tasks: Support regulatory strategies and ensure compliance for innovative IVD products globally.
- Company: Join a growing international in-vitro diagnostics organisation with a hands-on approach.
- Benefits: Gain international exposure and develop your career in a fast-paced environment.
- Why this job: Make a real impact on global health by ensuring product compliance and safety.
- Qualifications: Relevant degree or experience in Regulatory Affairs, especially in medical devices.
- Other info: Collaborate with cross-functional teams and enjoy excellent career growth opportunities.
The predicted salary is between 36000 - 60000 £ per year.
Mackinnon Bruce are partnered with a well-established and growing international in-vitro diagnostics (IVD) organisation to appoint a Regulatory Affairs Officer within its Regulatory Affairs function.
About the Role:
This is a hands-on regulatory role with international exposure, offering the opportunity to contribute to regulatory strategy and execution across multiple global markets. The position plays a key role in supporting product registrations, ensuring ongoing regulatory compliance, and maintaining technical documentation throughout the product lifecycle.
Working closely with cross-functional teams including R&D, Quality, Manufacturing, and Commercial, the Regulatory Affairs Officer will support regulatory submissions, liaise with regulatory authorities, and contribute to the continuous improvement of regulatory processes and systems within a fast-paced IVD environment.
Key Responsibilities:
- Support the development and execution of regulatory strategies for IVD products across global markets
- Prepare, compile, submit, and maintain regulatory documentation for regions including EU, US, Canada, and other international territories
- Ensure compliance with ISO 13485, IVD Directive 98/79/EC, IVDR (EU) 2017/746, FDA 21 CFR, and CMDR Part 1
- Coordinate regulatory submissions and advise internal teams on data and documentation requirements
- Support the preparation and maintenance of technical files and product registrations (EU, US, Canada, Japan, Brazil, etc.)
- Contribute to the development and review of product labelling, IFUs, and packaging to ensure regulatory compliance
- Liaise with regulatory authorities, notified bodies, customers, and external partners as required
- Maintain regulatory documentation in line with quality system and change control requirements
- Contribute to regulatory intelligence activities, monitoring regulatory updates and guidance
- Support audits, inspections, and general regulatory compliance activities
- Provide guidance and support to other Regulatory Affairs team members as needed
Requirements:
- Relevant degree and/or practical experience in a Regulatory Affairs environment
- Previous experience within medical devices and/or IVD
- Working knowledge of CE marking and FDA regulatory requirements
- Understanding of regulatory submissions such as 510(k), PMA, BLA, or CE technical documentation
- Strong technical writing and documentation skills
- Experience working to ISO 13485 and within a regulated quality system
- Ability to manage multiple priorities in a fast-paced environment
- Fluent English (written and spoken)
- Experience within an FDA-licensed manufacturing environment and exposure to global regulatory submissions is advantageous.
If you are interested in discussing the position further, please apply or reach out to me directly at Ben.birkhead@mackinnon-bruce.com.
Regulatory Affairs Officer in Scotland employer: Mackinnon Bruce International
Contact Detail:
Mackinnon Bruce International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer in Scotland
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory processes and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate!
✨Tip Number 3
Practice your pitch! Be clear about your skills and experiences that relate to the role of Regulatory Affairs Officer. A confident and concise introduction can make a great first impression.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace Regulatory Affairs Officer in Scotland
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, especially within the IVD or medical devices sector. We want to see how your background aligns with the key responsibilities outlined in the job description.
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 you can contribute to our team. Be sure to mention specific experiences that relate to the role, like your familiarity with ISO 13485 or regulatory submissions.
Showcase Your Technical Writing Skills: Since strong technical writing is crucial for this position, include examples of your documentation work in your application. Whether it's regulatory submissions or technical files, we want to see your ability to communicate complex information clearly and effectively.
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. This way, your application will be reviewed promptly, and you'll be one step closer to joining our dynamic team at StudySmarter!
How to prepare for a job interview at Mackinnon Bruce International
✨Know Your Regulations
Make sure you brush up on the key regulations relevant to the role, such as ISO 13485 and the IVD Directive. Being able to discuss these confidently will show that you understand the landscape and can navigate it effectively.
✨Prepare for Technical Questions
Expect questions about regulatory submissions like 510(k) and CE technical documentation. Prepare specific examples from your past experience where you successfully managed these processes, as this will demonstrate your hands-on knowledge.
✨Showcase Your Cross-Functional Experience
Since the role involves working with various teams, be ready to share examples of how you've collaborated with R&D, Quality, or Manufacturing in previous roles. Highlighting your teamwork skills will be crucial.
✨Stay Updated on Regulatory Changes
Regulatory affairs is always evolving, so make sure you're aware of the latest updates and guidance. Mentioning recent changes during your interview can show your proactive approach and commitment to continuous improvement.
