Regulatory Compliance Officer – Medical Devices

We are seeking a detail-oriented and knowledgeable Regulatory Compliance Officer to ensure our medical devices meet all applicable regulatory requirements and standards. The ideal candidate will play a critical role in overseeing compliance activities, preparing regulatory submissions, and collaborating with cross-functional teams to maintain product and process integrity throughout the device lifecycle.

• Monitor and interpret evolving regulations, standards, and guidance relevant to medical devices (e.g., FDA, ISO 13485, MDR)
• Ensure organizational practices and product development comply with national and international regulations
• Prepare, review, and submit regulatory documentation including device registrations, licenses, and clinical trial applications
• Act as a liaison with regulatory authorities and provide updates to internal teams
• Maintain thorough documentation of all regulatory activities, including correspondence, submissions, and audit records
• Identify potential compliance risks and implement mitigation strategies
• Conduct internal training sessions on regulatory standards and updates
• Participate in internal and external audits; ensure implementation of corrective actions
• Manage post-market surveillance activities, including adverse event reporting and trend analysis
• Design and implement regulatory compliance programs and standard operating procedures (SOPs)

• Strong analytical and problem-solving abilities to interpret regulatory requirements
• Excellent communication skills for effective interaction with regulatory agencies and internal stakeholders
• High attention to detail and strong organizational skills
• In-depth knowledge of regulatory standards and frameworks (e.g., US FDA 21 CFR, ISO 13485, EU MDR)
• Ability to manage multiple projects simultaneously and meet strict deadlines
• Strong understanding of medical device lifecycle, development, and manufacturing processes
• Proficient in MS Office and regulatory document management tools

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, or related discipline
• Experience in the medical device industry, specifically in regulatory or quality assurance
• Demonstrated understanding of regulatory submissions process and documentation
• Certifications in regulatory affairs (e.g., RAC) are a plus