Regulatory Affairs Business Specialist

Regulatory Affairs Business Specialist

In this role, you will support regulatory compliance and business objectives for our Image-Guided Therapy Devices business by coordinating regulatory activities and ensuring products meet relevant medical device standards and requirements.

Your role:

• Assists in implementing comprehensive regulatory strategies by collaborating with regulatory and cross-functional teams to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects.
• Demonstrates basic understanding of Regulatory's role in the Quality System with basic awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience.
• Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution.
• Assists in coordinating and developing conformity assessment strategies and plans essential for supporting regulatory submissions, ensuring alignment with regulatory requirements and standards.
• Supports the coordination and preparation of regulatory submissions for product/solution licensing, ensuring accuracy and completeness to expedite approval processes efficiently, managing files for device updates and related change control processes, supporting the Marketing Teams on Tender related issues.
• Participates in reviewing product/solution labeling and related marketing communications to ensure compliance with regulatory guidelines and standards, primarily at the Business and Field levels.
• Keeps abreast of regulatory procedures and changes, participates in process improvement activities related to internal regulatory processes, as well as evolving Regulatory Agency changes.

You're the right fit if:

• Experience in regulatory affairs, quality compliance, product development or equivalent in the medical device industry strongly preferred.
• Your skills include knowledge and experience working relevant medical device regulations and standards. Experience with Rimsys, SAP, and/or Windchill preferred.
• You have a bachelor’s degree or higher in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent required. RAPS RAC certification preferred but not required.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent communicator (written and verbal) with an ability to manage and prioritize multiple deliverables based on urgency.