Regulatory Affairs Specialist - Medical Devices

Industry: Medical Devices (Surgical Devices focus)

About the Role:
Kelly FSP is hiring a Regulatory Affairs Specialist to support our leading medical device client and drive regulatory compliance for surgical devices. In this role, you will play a key part in managing product modifications, regulatory registration, and portfolio strategy.

Key Responsibilities

• Prepare and submit regulatory registration documents and notifications for surgical devices.

• Provide regulatory guidance on product changes and device modifications.

• Contribute to strategic planning and portfolio management within Regulatory Affairs.

• Advise local business partners and coordinate with Regulatory Affairs teams.

• Communicate with local distributors regarding portfolio changes.

• Ensure ongoing compliance with regulatory agency requirements.

• Address inquiries from regulatory agencies by preparing thorough responses.

• Create deliverables such as summaries, status reports, outlines, and visual presentations.

• Provide solutions to moderately complex regulatory challenges.

• Conduct file searches and deliver requested regulatory information.

• Manage and archive all regulatory documentation.

Qualifications

• Bachelor’s degree in a technical field required; Master’s degree is a plus.

• 2–5 years’ experience in Regulatory Affairs or a relevant field.

• In-depth knowledge of Russian regulatory requirements for medical devices.

• Previous experience registering medical devices with local health authorities.

• Strong problem-solving abilities and process improvement skills.

• Experience with surgical devices preferred.

• Ability to work both independently and as part of a team.

Opportunities

• Work on innovative surgical device projects that shape the future of healthcare.

• Grow your career in a dynamic, fast-growing industry.

• Enjoy significant opportunities for career and professional development.

Our Culture

At Kelly FSP, our core values are innovation, integrity, and collaboration. Join our passionate team to make a meaningful impact on surgical device innovation and patient care, all within a supportive and growth-oriented environment.

Ready to Apply?
Send your resume and a brief cover letter to [Contact Email].
Kelly FSP is an equal opportunity employer. All qualified applicants will receive consideration.