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For Companies At a Glance
- Tasks: Develop regulatory strategies and manage product license registrations globally.
- Company: Leading healthcare organisation focused on innovation and compliance.
- Benefits: Supportive environment with opportunities for growth and impact.
- Why this job: Join a forward-thinking team and make a real difference in healthcare.
- Qualifications: Degree in regulatory affairs or equivalent experience required.
- Other info: Fast-paced environment with a focus on collaboration and continuous improvement.
The predicted salary is between 36000 - 60000 £ per year.
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.
The 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 - SRG employer: Jobster
Contact Detail:
Jobster Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer - SRG
✨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 creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise.
✨Tip Number 3
Showcase your technical writing skills! Bring along samples of your previous work or create a mock regulatory document to demonstrate your abilities. We want to see how you can communicate complex information clearly.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Regulatory Affairs Officer - SRG
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Regulatory Affairs Officer role. Highlight your experience with regulatory submissions and compliance, especially in medical devices, to catch our eye!
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 aligns with our client's mission in healthcare and diagnostics.
Showcase Your Technical Writing Skills: Since excellent technical writing is key for this role, include examples of your previous work or projects where you’ve had to prepare regulatory documentation. This will demonstrate your capability right off the bat!
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’re considered for this exciting opportunity in a fast-paced environment!
How to prepare for a job interview at Jobster
✨Know Your Regulations
Make sure you brush up on the key regulations like CE and FDA guidelines. Being able to discuss specific submissions like PMA, BLA, and 510(k) will show that you’re not just familiar with the terms but understand their implications in real-world scenarios.
✨Prepare Your Documentation
Since you'll be dealing with regulatory documentation, it’s crucial to have examples ready. Bring along samples of previous submissions or documentation you've worked on. This will demonstrate your hands-on experience and attention to detail.
✨Showcase Your Communication Skills
As a Regulatory Affairs Officer, you'll need to liaise with various stakeholders. Be prepared to discuss how you've effectively communicated complex regulatory requirements to non-experts in the past. This will highlight your ability to bridge gaps between technical and non-technical teams.
✨Stay Updated on Industry Changes
Regulatory affairs is a constantly evolving field. Make sure you’re aware of recent changes in regulations or standards, especially those related to ISO13485 and IVD directives. Mentioning these during your interview will show that you’re proactive and committed to compliance.
