Regulatory Affairs Specialist

The Regulatory Affairs Specialist will play a key role in supporting regulatory strategy and compliance throughout the product lifecycle. Reporting to the Global Product Director, this individual will partner closely with Engineering, Quality, Operations, Manufacturing, and external regulatory consultants to support both commercial products and new product development.

This position will focus heavily on FDA and EU MDR regulatory activities while supporting multiple new product launches over the coming years. The successful candidate will also mentor a junior Regulatory Affairs Specialist and help develop future regulatory talent through internship programs as the organization continues to grow.

Working with your regulatory and quality team members, you will:

• Develop and execute regulatory strategies supporting Class II medical devices throughout the product lifecycle.
• Prepare, maintain, and submit FDA 510(k) regulatory submissions and support international registrations as needed.
• Lead EU MDR compliance activities, including maintenance of Technical Documentation, Essential Requirements Checklists, and Declarations of Conformity.
• Maintain knowledge of evolving FDA, EU MDR, and other global regulatory requirements to ensure ongoing compliance.
• Serve as the Regulatory Affairs representative on cross-functional product development teams supporting three active new product development programs.
• Review engineering change orders and assess regulatory impact for product and process changes.
• Maintain compliance with existing regulatory submissions and determine appropriate regulatory pathways for product modifications.
• Develop and maintain regulatory procedures and documentation supporting the Quality Management System.
• Partner with external regulatory consultants, Notified Bodies, and regulatory agencies as needed.
• Support regulatory inspections, audits, and agency interactions to ensure successful outcomes.
• Collaborate with Quality, Engineering, Manufacturing, and Product Development teams to successfully commercialize new products.
• Mentor and develop a junior Regulatory Affairs Specialist while helping build future regulatory talent through internship programs.
• Balance thorough regulatory analysis with timely execution to keep projects moving while maintaining compliance.

Requirements:

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related field.
• Minimum of three years of Regulatory Affairs experience within the medical device industry.
• Strong knowledge of FDA regulations, including experience supporting or preparing 510(k) submissions.
• Working knowledge of EU MDR requirements and CE Technical Documentation.
• Experience supporting Class II medical devices throughout development and commercialization.
• Understanding of Design Controls, engineering change processes, and regulatory impact assessments.
• Excellent organizational, communication, and cross-functional collaboration skills.
• Ability to manage multiple priorities while maintaining attention to detail and meeting project timelines.
• Medical device manufacturing experience preferred.
• Candidates should be comfortable using Microsoft Office programs and possess excellent interpersonal skills.
• Candidates shall be able to operate a motor vehicle and travel domestically and internationally as needed.