Job Description
Job DescriptionOpportunity Highlights
- Play a key role in shaping global regulatory strategy for innovative surgical technologies.
- Lead regulatory submissions across multiple markets, supporting meaningful product advancements.
- Join a high-growth organization where RA is viewed as a strategic partner, not a checkbox function.
Role Overview
The Senior Regulatory Affairs Specialist will develop and execute regulatory strategies, supporting both new product development and global expansion efforts. You will prepare submissions, maintain compliance with evolving global regulations, and serve as the regulatory voice on cross-functional teams. This role requires strong understanding of medical device regulations, excellent communication skills, and the ability to guide teams through complex regulatory pathways.Key Responsibilities
- Develop and implement regulatory strategies for new and existing devices.
- Prepare submissions including 510(k)s, amendments, supplements, and technical documentation.
- Maintain current knowledge of global regulations, standards, and state-of-the-art requirements.
- Lead efforts to align products with new or updated regulatory requirements.
- Provide regulatory input during product development and throughout the product lifecycle.
- Collaborate with commercial teams to ensure compliant labeling, advertising, and promotional materials.
- Interface with FDA, Notified Bodies, and other regulatory authorities as needed.
Requirements
- 4–8+ years of experience in medical device regulatory affairs (flexible on level).
- Permanent authorization to work in the United States.
- Experience supporting devices with both hardware and software components.
- Familiarity with global regulatory requirements including MDSAP, EU MDR, and ISO 13485.
- Strong communication skills and ability to collaborate across technical and commercial teams.
- Attention to detail and ability to manage multiple projects concurrently.
- Bachelor’s degree in Engineering, Science, Regulatory Affairs, or related field.
- RAC certification is a plus.
Work Authorization
This position requires permanent authorization to work in the United States. At this time, the employer is not able to sponsor or assume sponsorship of employment visas for this role.About MedTech Talent Solutions
MedTech Talent Solutions partners exclusively with medtech companies to connect exceptional talent with opportunities that shape the future of healthcare technology. We present a menu of recruiting solutions from which clients can choose, tailoring our approach to their unique needs. Our expertise is grounded in real-world experience, having served as internal recruiters inside some of the most demanding and highest-performing medtech companies. That insider perspective allows us to deliver with the precision, pace, and discretion the industry demands. Every application is reviewed by an experienced recruiter, and we treat each candidate’s goals with care and respect.Our mission is simple: to create matches that are successful, lasting, and meaningful — to candidates and, ultimately, to patients.Ready to Learn More?
Apply through this posting or connect with us directly. We will share additional details with qualified candidates after an initial conversation.