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For Companies At a Glance
- Tasks: Develop regulatory strategies and manage product license registrations globally.
- Company: Leading healthcare and diagnostics organisation focused on innovation and compliance.
- Benefits: Supportive environment with opportunities for growth and impactful contributions.
- Why this job: Join a forward-thinking team and make a real difference in healthcare.
- Qualifications: Degree in regulatory affairs or equivalent experience, with strong knowledge of CE and FDA regulations.
- Other info: Fast-paced environment with opportunities for collaboration and continuous improvement.
The predicted salary is between 36000 - 60000 Ā£ 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 fastāpaced 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 fastāpaced environment.
- Exceptional attention to detail, time management, and problemāsolving skills.
Desirable
- Experience working within an FDAālicensed manufacturing facility.
- Previous involvement in global regulatory submissions beyond core regions.
Why Apply
This is a fantastic opportunity to join a forwardāthinking 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 in Edinburgh employer: Jobster
Contact Detail:
Jobster Recruiting Team
StudySmarter Expert Advice š¤«
We think this is how you could land Regulatory Affairs Officer - SRG in Edinburgh
āØTip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We canāt stress enough how valuable personal connections can be in landing that dream job.
āØTip 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.
āØTip Number 3
Showcase your technical writing skills! Bring along samples of your previous work or create a portfolio that highlights your ability to prepare regulatory documentation. This will set you apart from other candidates.
āØTip Number 4
Donāt forget to apply through our website! Itās the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Affairs Officer - SRG in Edinburgh
Some tips for your application š«”
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Regulatory Affairs Officer role. Highlight your previous 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. Keep it engaging and relevant!
Showcase Your Technical Writing Skills: Since excellent technical writing is key for this role, include examples of your writing in your application. Whether it's reports, regulatory documents, or any other relevant materials, let us see your skills in action!
Apply Through Our Website: We encourage you to apply directly through our website. Itās the best way for us to receive your application and ensures you donāt miss out on any important updates during the process!
How to prepare for a job interview at Jobster
āØKnow Your Regulations
Make sure you brush up on the key regulations like ISO13485, IVD Directive 98/79/EC, and FDA CFRs. Being able to discuss these confidently will show that youāre not just familiar with the requirements but also understand their implications in real-world scenarios.
āØPrepare Your Documentation
Since you'll be dealing with regulatory documentation, itās crucial to have examples ready. Bring along any relevant documents you've worked on, such as submissions or technical files, to demonstrate your experience and attention to detail.
āØShowcase 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 information in the past, whether to internal teams or external authorities.
āØStay Updated on Industry Changes
Regulatory affairs is always evolving, so show your enthusiasm for staying current. Mention any recent changes in regulations or trends in the healthcare sector that youāve been following, and how you think they might impact the role.
