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For Companies At a Glance
- Tasks: Manage product licence registration and ensure compliance with global regulatory requirements.
- Company: Join a leading international medical device manufacturer in Edinburgh.
- Benefits: Competitive salary, diverse benefits, and personal development opportunities.
- Why this job: Make a real impact in the medical device sector while working with a multinational team.
- Qualifications: Experience in regulatory roles, especially within medical devices, is essential.
- Other info: Dynamic work environment with opportunities for career growth.
The predicted salary is between 36000 - 60000 £ per year.
SRG are delighted to be working with an internationally renowned medical device manufacturer. As part of continued growth, this organisation is looking for a Senior Regulatory Affairs (RA) Officer to join their team in the greater Edinburgh area.
The Role
As Senior RA Officer, you will work as part of a large, multinational team to help manage and deliver product licence registration, working in collaboration with regulatory bodies across the globe. As a key part of the RA team, you will help build the company's regulatory strategy, determine requirements and propose solutions to ensure compliance. On a day-to-day basis, this involves the preparation of regulatory documentation and subsequent submission across the US, UK and EU as well as other appropriate territories in line with local guidance. You will be required to work closely with internal and external stakeholders to ensure all staff and vendors are kept aware of developments and changes in global regulatory requirements. As Senior RA Officer, you will also be responsible for managing and confirming compliance issues both internally and externally, ensuring all relevant documentation is kept accurate and up-to-date.
The Right Person
- Prior experience in a regulatory role - ideally within an FDA licensed manufacturing facility.
- Significant previous experience within the medical device sector is essential; anyone with prior experience working with IVDs would be preferential.
- Excellent communication skills are essential.
- Expert-level knowledge of CE and FDA regulations, including PMA, BLA, and 510(k) submissions.
- Demonstrable experience supporting regulatory audits and inspections.
What’s in it for you?
This position offers a competitive base salary with a wide array of benefits available. As well as this, you will be offered a variety of opportunities for personal development working within a large multi-national team.
Senior Regulatory Affairs Officer employer: SRG
Contact Detail:
SRG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior 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 Senior RA Officer role.
✨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, especially around PMA, BLA, and 510(k) submissions. This will show you’re not just familiar but an expert!
✨Tip Number 3
Don’t forget to showcase your experience with regulatory audits and inspections during interviews. We suggest using the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements effectively.
✨Tip Number 4
Apply through our website for the best chance at landing the job! We make it easy for you to submit your application directly, and you’ll be one step closer to joining a fantastic team in the medical device sector.
We think you need these skills to ace Senior Regulatory Affairs Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Officer role. Highlight your experience in regulatory roles, especially within the medical device sector, and showcase your knowledge of CE and FDA regulations.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this position. Share specific examples of your past experiences that align with the job description, particularly around product licence registration and compliance management.
Showcase Your Communication Skills: Since excellent communication skills are essential for this role, make sure to demonstrate these in your application. Use clear and concise language, and consider including examples of how you've effectively communicated with stakeholders in the past.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. This way, we can easily track your application and ensure it reaches the right people in our team!
How to prepare for a job interview at SRG
✨Know Your Regulations
Make sure you brush up on your knowledge of CE and FDA regulations, especially PMA, BLA, and 510(k) submissions. Being able to discuss these in detail will show that you're not just familiar with the requirements but can also navigate them effectively.
✨Showcase Your Experience
Prepare specific examples from your previous roles that highlight your experience in regulatory affairs, particularly within the medical device sector. Be ready to discuss how you've managed compliance issues and supported audits, as this will demonstrate your hands-on expertise.
✨Communicate Clearly
Since excellent communication skills are essential for this role, practice articulating your thoughts clearly and concisely. Think about how you would explain complex regulatory concepts to stakeholders who may not have a technical background.
✨Engage with the Team
Research the company’s culture and values, and be prepared to discuss how you can contribute to their multinational team. Showing that you understand the importance of collaboration in regulatory affairs will set you apart as a candidate who fits well within their environment.
