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For Companies At a Glance
- Tasks: Manage product license registration and ensure compliance with global regulatory standards.
- 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 within FDA licensed facilities and knowledge of CE and FDA regulations.
- Other info: Dynamic work environment with opportunities for career growth and development.
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 license 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 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 in Dunfermline employer: SRG
Contact Detail:
SRG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Officer in Dunfermline
✨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. Show them you know your stuff!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest checking out our website for openings that match your expertise in medical devices and regulatory compliance.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We believe it shows your enthusiasm and professionalism, which is crucial in the regulatory affairs sector.
We think you need these skills to ace Senior Regulatory Affairs Officer in Dunfermline
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in regulatory affairs, especially within the medical device sector. We want to see how your skills align with the requirements mentioned in the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the Senior RA Officer role. Share specific examples of your past experiences that relate to the responsibilities outlined in the job description.
Showcase Your Communication Skills: Since excellent communication skills are essential for this role, make sure your application reflects this. Keep your language clear and concise, and don’t hesitate to demonstrate your ability to collaborate with various stakeholders.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates!
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. Discuss any challenges you faced and how you overcame them, especially in relation to compliance issues.
✨Communicate Clearly
Since excellent communication skills are essential for this role, practice articulating your thoughts clearly and concisely. Be ready to explain complex regulatory concepts in a way that’s easy to understand, as you’ll need to work closely with various stakeholders.
✨Stay Updated on Global Changes
Research recent changes in global regulatory requirements and be prepared to discuss how they might impact the company. Showing that you’re proactive about staying informed will demonstrate your commitment to the role and the industry.
