Regulatory Affairs Specialist

This role will focus on obtaining and maintaining regulatory approvals in international markets while ensuring ongoing compliance with applicable regulations and standards. The Regulatory Specialist will collaborate closely with cross-functional teams, regulatory authorities, distributors, and notified bodies to facilitate successful global product registrations and market expansion.

Responsibilities:

• Prepare, compile, submit, and maintain regulatory submissions for devices in international markets, including registrations, renewals, amendments, and product change notifications.
• Support regulatory market expansion initiatives by researching country-specific regulatory requirements and developing submission strategies.
• Coordinate regulatory activities for new product launches and lifecycle management across global markets.
• Monitor changes in international medical device regulations, guidance documents, and standards, and communicate impacts to internal stakeholders.
• Maintain regulatory documentation, including technical files, declarations of conformity, labeling, and supporting documentation required for international submissions.
• Collaborate with Research & Development, Quality Assurance, Clinical, Manufacturing, Marketing, and Supply Chain teams to ensure regulatory requirements are incorporated throughout the product lifecycle and the quality management system.
• Work with international distributors, in-country representatives, consultants, and regulatory agencies to facilitate timely product registrations.
• Assist with regulatory assessments for design changes, labeling updates, manufacturing changes, and post-market activities.
• Participate in internal and external audits and support responses to regulatory agency inquiries.

Qualifications

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, Biology, Chemistry, or a related scientific field preferred.
• 1-3 years of regulatory affairs experience within the medical device industry preferred.
• Working knowledge of U.S. FDA medical device regulations, ISO 13485 and ISO 14971.
• Experience preparing or supporting international regulatory submissions.
• Familiarity with medical device quality systems and risk management principles.
• Strong technical writing, documentation, organizational skills, and communication.
• Familiarity with global regulatory frameworks and submission processes, including country-specific registration requirements.

Working conditions

• Standard office and manufacturing environment
• Must be eligible to work in the U.S. and provide proper documentation within 3 days of employment
• Must successfully pass background screening and drug screening
• Occasional travel to suppliers, customers, or other sites, not to exceed 15%

Physical requirements

• Frequent walking, standing, or sitting for extended periods of time.

May occasionally push, pull, or lift up to 25-50 pounds.