Regulatory Affairs Specialist

Key Responsibilities:

• Prepare and submit regulatory submissions including 510(k), PMA, Technical Files, Design Dossiers, and CE Marking applications.
• Support the development and implementation of global regulatory strategies for new product development and product changes.
• Liaise with regulatory bodies (e.g., FDA, Notified Bodies, Health Canada) and respond to requests for additional information.
• Maintain regulatory documentation and ensure timely updates in alignment with product lifecycle changes.
• Collaborate cross-functionally with R&D, Quality Assurance, Clinical Affairs, and Marketing to ensure regulatory requirements are met throughout product development.
• Monitor and interpret regulatory requirements, guidance documents, and standards to ensure ongoing compliance.
• Support product labeling, advertising, and promotional material review for regulatory compliance.
• Participate in internal and external audits and inspections, including FDA inspections and Notified Body audits.
• Maintain regulatory files and tracking tools for submissions, approvals, and ongoing compliance activities.
• Provide regulatory support for risk management, change control, and CAPA processes.
• Assist in compiling periodic reports and renewals for global registrations and licenses.

Required Qualifications:

• Bachelor’s degree in a scientific, engineering, or healthcare-related discipline (e.g., Regulatory Affairs, Biomedical Engineering, Biology, etc.).
• 3 years of regulatory affairs experience in the medical device industry, including work with Class II and/or Class III devices.
• Hands-on experience with FDA 510(k) and/or PMA submissions and EU MDR Technical Documentation.
• Knowledge of U.S. FDA regulations (21 CFR Part 820), EU Medical Device Regulation (MDR 2017/745), ISO 13485, and ISO 14971.
• Familiarity with international regulatory requirements (e.g., Health Canada, TGA, ANVISA, PMDA) is a plus.
• Strong attention to detail, organizational skills, and ability to manage multiple projects and deadlines.
• Excellent verbal and written communication skills.
• Proficient in MS Office Suite and document control systems.