Overview The Regulatory Affairs Specialist is responsible for supporting regulatory compliance activities for a well-established medical device organization and ensuring products meet applicable U.S. and international regulatory requirements throughout their lifecycle. The role provides hands-on regulatory support for EU MDD to MDR transition activities, ongoing regulatory maintenance, audit readiness, and recall preparedness. This position supports the preparation, maintenance, and review of regulatory documentation, including technical documentation, labeling, and change impact assessments. The Regulatory Affairs Specialist works cross-functionally with Quality, R&D, Manufacturing, Supply Chain, and Operations to support regulatory compliance related to product changes, audits, and post-market activities. The role also supports regulatory inspections and audits, assists with regulatory responses and documentation requests, and helps ensure the organization maintains compliance with applicable regulations and standards. Responsibilities Support regulatory compliance activities to ensure medical device products meet applicable U.S. and international regulatory requirements throughout the product lifecycle. Prepare, update, and maintain regulatory documentation, including technical documentation, labeling, and regulatory records. Support EU MDD to MDR transition activities, including documentation updates and remediation support. Support regulatory audits and inspections (ISO 13485, Notified Body, and regulatory authority), including audit preparation and follow-up activities. Support recall and field action readiness, including documentation maintenance and regulatory communication support as needed. Support regulatory impact assessments for product, process, supplier, and labeling changes. Work cross-functionally with Quality, R&D, Manufacturing, Supply Chain, and Operations to ensure regulatory requirements are considered in operational activities. Support compliance of product labeling and instructions for use with applicable regulatory requirements. Monitor regulatory changes and support assessment of potential impact on existing products and processes. Coordinate with external regulatory consultants as needed. Required Qualifications Bachelor's degree in a related field (e.g., life sciences, engineering, regulatory affairs). Minimum of 4-6 years of experience in regulatory affairs in the medical device industry. Working knowledge of US and international medical device regulatory requirements and guidelines (e.g., FDA and EU MDD/MDR). Experience supporting regulatory documentation, including technical documentation and labeling. Strong written and verbal communication skills. Strong organizational and project management skills. Ability to work effectively in a team environment and manage multiple projects simultaneously. Preferred Qualifications Experience supporting EU MDD to MDR transition activities, including documentation updates or remediation efforts. Familiarity with EU MDR technical documentation requirements. Experience supporting regulatory submissions for U.S and/or international markets, such as 510(k) applications. Experience supporting regulatory audits or inspections, including ISO 13485 or Notified Body audits. Experience supporting recall or field action activities. Regulatory Affairs Certification (RAC) or progress towards certification. Physical / Mental Demands Working conditions are normal for an office environment. Work may require weekend and evening work. Work under stress in a fast-paced environment. Must be alert, able to concentrate, and use good judgment. Must be able to work under conditions that require sitting, standing, and walking. #J-18808-Ljbffr