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- Tasks: Develop regulatory strategies and manage product license registrations globally.
- Company: Leading healthcare organisation focused on innovation and compliance.
- Benefits: Permanent position with a supportive environment and career growth.
- Why this job: Make a real impact in a fast-paced, innovative sector.
- Qualifications: Degree in regulatory affairs or equivalent experience required.
- Other info: Join a collaborative team and enhance your skills in regulatory compliance.
The predicted salary is between 36000 - 60000 £ per year.
Location: Edinburgh - On site
Employment Type: Permanent
About Our Client: Our client is a leading organisation in the healthcare and diagnostics sector, committed to delivering innovative solutions and maintaining the highest standards of regulatory compliance. They are seeking a skilled Regulatory Affairs Officer to join their team and play a key role in ensuring global regulatory compliance and supporting product registrations.
Our Role: As a Regulatory Affairs Officer, you will be responsible for developing regulatory strategies, managing product license registrations worldwide, and advising on compliance requirements. This is an exciting opportunity to work in a fast‑paced environment where your expertise will directly contribute to the success of the business.
Key Responsibilities
- Prepare and compile regulatory documentation and coordinate submissions for global markets, including US, EU, Canada, and others.
- Advise internal teams on data requirements for successful license applications.
- Develop and maintain product labelling requirements and liaise with stakeholders.
- Monitor regulatory changes and maintain compliance with ISO13485, IVD Directive 98/79/EC, IVD Regulation 2017/746, FDA CFRs, and other global standards.
- Maintain technical files and regulatory documents for multiple territories.
- Communicate effectively with regulatory authorities and external bodies.
- Support process improvements and provide guidance and training to team members.
What We're Looking For
- A relevant degree or equivalent experience in regulatory affairs.
- Previous experience in regulatory submissions and compliance within medical devices or related industries.
- Strong knowledge of CE and FDA regulations, including PMA, BLA, and 510(k) submissions.
- Excellent technical writing skills and proficiency in MS Office.
- Ability to work independently and collaboratively in a fast‑paced environment.
- Exceptional attention to detail, time management, and problem‑solving skills.
Desirable
- Experience working within an FDA‑licensed manufacturing facility.
- Previous involvement in global regulatory submissions beyond core regions.
Why Apply?
This is a fantastic opportunity to join a forward‑thinking organisation that values innovation, collaboration, and continuous improvement. Our client offers a supportive environment where your contributions will make a real impact.
Regulatory Affairs Officer employer: SRG
Contact Detail:
SRG 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 CE and FDA regulations. We recommend practising common interview questions related to regulatory compliance, so you can showcase your expertise confidently.
✨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 simple thank-you email can set you apart from other candidates. We believe it shows your enthusiasm and professionalism, which are key in the regulatory affairs sector.
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, especially within medical devices. We want to see how your skills align 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 background makes you a great fit for our team. Keep it concise but impactful – we love a good story!
Show Off Your Technical Writing Skills: Since excellent technical writing is key for this role, make sure your application showcases your writing abilities. Whether it's through your CV, cover letter, or any additional documents, clarity and precision are essential – we’re all about that attention to detail!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates. Plus, it shows us you’re keen to join our innovative team!
How to prepare for a job interview at SRG
✨Know Your Regulations
Familiarise yourself with the key regulations mentioned in the job description, like ISO13485 and FDA CFRs. Being able to discuss these confidently will show that you’re not just a candidate, but a knowledgeable professional ready to contribute.
✨Prepare Your Documentation
Since the role involves preparing regulatory documentation, bring examples of your past work or be ready to discuss how you've successfully managed submissions. This will demonstrate your hands-on experience and attention to detail.
✨Showcase Your Communication Skills
Effective communication with regulatory authorities is crucial. Be prepared to share examples of how you've successfully liaised with stakeholders or navigated complex compliance issues in the past.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s approach to regulatory compliance and product registrations. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.