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- Tasks: Support regulatory strategy and compliance for innovative IVD products across global markets.
- Company: Join a growing international in-vitro diagnostics organisation with a hands-on approach.
- Benefits: Gain international exposure, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in the healthcare sector while working with cross-functional teams.
- Qualifications: Relevant degree or experience in Regulatory Affairs, especially in medical devices or IVD.
- Other info: Dynamic environment with opportunities to contribute to regulatory processes and systems.
The predicted salary is between 30000 - 50000 £ 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. 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.
- 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.
- 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.
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. Fluent English (written and spoken). Experience within an FDA-licensed manufacturing environment and exposure to global regulatory submissions is advantageous.
Regulatory Affairs Officer - Pharmaceuticals 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 - Pharmaceuticals in Scotland
✨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 when it comes to landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory compliance and product lifecycle management. We recommend practising common interview questions related to IVD products and being ready to discuss your previous experiences in detail.
✨Tip Number 3
Showcase your skills! Create a portfolio that highlights your technical writing and documentation abilities. We believe having tangible examples of your work can really set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it’s super easy to keep track of your applications!
We think you need these skills to ace Regulatory Affairs Officer - Pharmaceuticals 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 in IVD or medical devices. We want to see how your background aligns with the job description!
Showcase Your Skills: Don’t forget to showcase your strong technical writing skills! Include examples of documentation you've prepared, like regulatory submissions or product labelling. This will help us see your attention to detail and understanding of regulatory requirements.
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 any specific regulations you’re familiar with, like ISO 13485 or FDA guidelines.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
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, like ISO 13485 and the IVD Directive. Being able to discuss these confidently will show that you’re not just familiar with the requirements but also understand their implications in a real-world context.
✨Showcase Your Technical Writing Skills
Prepare examples of your technical writing from previous roles, especially any regulatory documentation you've worked on. This could include submissions or compliance reports. Being able to articulate your experience in this area will highlight your suitability for the role.
✨Understand the Company’s Products
Research the company’s in-vitro diagnostic products and their market presence. Knowing their product lines and recent developments will help you tailor your answers and demonstrate genuine interest during the interview.
✨Prepare for Cross-Functional Collaboration
Think about how you’ve worked with teams like R&D, Quality, and Manufacturing in the past. Be ready to share specific examples of how you’ve contributed to regulatory submissions or improved processes, as this role requires strong collaboration across various departments.
