Regulatory Affairs Specialist

Primary Responsibilities

• Prepare, review, and submit US regulatory documentation, including IDEs, PMAs, PMA Supplements, and 510(k) submissions.
• Evaluate and ensure the accuracy and completeness of technical and clinical documentation for US registrations.
• Collaborate with global regulatory colleagues to align submission strategies and documentation.
• Support discussions with CROs, external consultants, and FDA representatives in coordination with senior regulatory leaders.
• Review labeling, instructions for use (IFUs), and promotional materials for compliance with US regulations.
• Ensure adherence to FDA regulations, including 21 CFR 807, 812, and 814, as well as applicable guidance for PMA and 510(k) submissions.
• Participate in audits and FDA inspections as a subject matter expert in Regulatory Affairs.
• Maintain accurate regulatory records and tracking systems in compliance with ISO 13485 and internal quality procedures.
• Monitor changes in US regulatory requirements and assess their impact on products and documentation.

Skills & Requirements

• Bachelor’s degree in Regulatory Affairs, Biology, Biomedical Engineering, Life Sciences, or a related field.
• Experience preparing, reviewing, and submitting regulatory documentation, particularly for Class III medical devices.
• Strong understanding of US FDA regulatory pathways, including PMA and/or 510(k) processes.
• Familiarity with ISO 13485, ISO 14971, and FDA Quality System Regulations (QSR).
• Proficiency in using regulatory information management systems or submission tools.
• Experience working with CROs or external partners for regulatory submissions.
• Adaptable, detail-oriented, and proactive, with strong organizational and communication skills.
• Ability to work independently in a remote setting while collaborating effectively with global teams.