Job Title : Regulatory Compliance Officer – Medical Devices Location : Chandigarh Department : Regulatory Affairs / Quality Assurance Experience : minimum 3 years Job Type : Full-time Job Summary: 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. Key Responsibilities: 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). Required Skills and Competencies: 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. Qualifications: Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related discipline. Experience in the medical device industry, specifically in regulatory affairs or quality assurance. Demonstrated understanding of regulatory submission processes and documentation. Certifications in regulatory affairs (e.g., RAC) are a plus. To Apply: Send your updated resume to hr@sysmed.co.in For more information, contact +91 90566 99984 Show more Show less