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- Tasks: Lead FDA 510(k) submissions and ensure compliance with global regulatory standards.
- Company: Join an innovative medical device manufacturer focused on quality and growth.
- Benefits: Enjoy a dynamic work environment with opportunities for professional development.
- Why this job: Be part of a team that impacts global health through compliant medical devices.
- Qualifications: Bachelor’s degree in relevant fields and 3 years of regulatory experience required.
- Other info: RAC certification is a plus; strong communication skills are essential.
The predicted salary is between 36000 - 60000 £ per year.
Arevna is partnering with an innovative and growth-focused medical device manufacturer to recruit a Regulatory Specialist with hands-on experience in 510(k) submissions and MDSAP compliance. This is a fantastic opportunity to join a company committed to delivering high-quality, compliant products to global markets.
Key Responsibilities:
- Lead or support the preparation and submission of FDA 510(k) applications for Class II medical devices.
- Ensure the company’s Quality Management System and product documentation meet MDSAP audit requirements across applicable markets (e.g., US, Canada, Australia, Brazil, Japan).
- Liaise with cross-functional teams to compile technical documentation and support global regulatory strategies.
- Interpret and implement evolving regulatory requirements in target markets.
- Act as a point of contact during audits and inspections, including FDA, MDSAP, and notified body reviews.
- Maintain comprehensive and organized regulatory files for both pre-market and post-market activities.
- Support post-market regulatory compliance, including vigilance reporting and regulatory updates.
Candidate Profile:
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
- Minimum 3 years of experience in regulatory affairs within the medical device industry.
- Demonstrated experience preparing and submitting FDA 510(k) applications.
- Solid understanding of and practical experience with MDSAP requirements.
- Knowledge of international medical device regulations (e.g., FDA, EU MDR, ISO 13485, Health Canada, TGA, ANVISA).
- Strong organizational and project management skills.
- Excellent communication and interpersonal skills.
- RAC certification or similar credential is a plus.
Sr. Regulatory Specialist employer: Arevna
Contact Detail:
Arevna Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr. Regulatory Specialist
✨Tip Number 1
Familiarise yourself with the specific requirements for FDA 510(k) submissions and MDSAP compliance. Understanding these regulations inside out will not only boost your confidence but also allow you to speak knowledgeably during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with medical devices. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 3
Prepare to discuss specific examples from your past experience where you successfully navigated regulatory challenges or led a project related to 510(k) submissions. This will demonstrate your hands-on expertise and problem-solving skills to potential employers.
✨Tip Number 4
Stay updated on changes in international medical device regulations. Being knowledgeable about evolving standards will show your commitment to the field and your ability to adapt, making you a more attractive candidate for the role.
We think you need these skills to ace Sr. Regulatory Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory affairs, particularly with FDA 510(k) submissions and MDSAP compliance. Use specific examples to demonstrate your expertise and achievements in these areas.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your passion for the medical device industry and your understanding of regulatory requirements. Mention how your background aligns with the key responsibilities of the role and why you want to work with Arevna's partner company.
Highlight Relevant Skills: In your application, emphasise your strong organisational and project management skills. Provide examples of how you've successfully managed regulatory projects or audits in the past, showcasing your ability to liaise with cross-functional teams.
Showcase Continuous Learning: If you have any additional certifications, such as RAC or similar credentials, be sure to mention them. Highlight any ongoing education or training related to international medical device regulations to demonstrate your commitment to staying updated in the field.
How to prepare for a job interview at Arevna
✨Showcase Your Regulatory Knowledge
Make sure to brush up on your knowledge of FDA 510(k) submissions and MDSAP compliance. Be prepared to discuss specific examples from your past experience that demonstrate your understanding of these processes.
✨Highlight Cross-Functional Collaboration
Since the role involves liaising with cross-functional teams, be ready to share instances where you successfully collaborated with other departments. This will show your ability to work well in a team-oriented environment.
✨Prepare for Technical Questions
Expect technical questions related to regulatory requirements and compliance. Review key regulations such as ISO 13485 and EU MDR, and be prepared to explain how you've applied them in your previous roles.
✨Demonstrate Organisational Skills
Given the importance of maintaining comprehensive regulatory files, be ready to discuss your organisational strategies. Share how you manage documentation and ensure compliance during audits and inspections.
