Regulatory Affairs Specialist

About the role

Join a Growing Medical Device Company Making a Difference
Are you passionate about regulatory compliance, technical documentation, and bringing innovative medical devices to market? We are seeking a detail-oriented Regulatory Affairs Specialist to support regulatory submissions, product registrations, and compliance activities across U.S. and international markets.

Responsibilities

• Prepare and support regulatory submissions, including FDA 510(k) and PMA applications.
• Create, maintain, and update technical documentation, technical files, and design dossiers for international markets.
• Manage product registrations, license renewals, and annual regulatory filings.
• Support adverse event reporting and vigilance reporting activities.
• Monitor and interpret evolving regulatory requirements and standards.
• Coincide with regulatory agencies and notified bodies as needed.
• Review product labeling, manufacturing processes, and documentation to ensure regulatory compliance.
• Assist with regulatory strategies for new product development and product changes.
• Partner with R&D and Quality teams to facilitate timely regulatory approvals.

Requirements

• Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, or a related field.
• 1–3 years of experience in Regulatory Affairs, Quality, or Compliance within a regulated industry.
• Strong technical writing and documentation skills.
• Excellent organizational skills and attention to detail.
• Ability to manage multiple projects and deadlines simultaneously.
• Strong communication and cross-functional collaboration skills.

Preferred Qualifications

• Medical device industry experience.
• Experience with FDA regulations and regulatory submissions.
• Familiarity with ISO 13485, Design Controls, CAPA, and Risk Management.
• Exposure to EU Medical Device Regulation (MDR) requirements.
• RAPS membership or pursuit of RAC certification.
• Bilingual (English/Spanish) preferred.