Regulatory Affairs Officer (Medical equipment Male candidate)

Job Description

Prepare and submit regulatory documentation for new and existing products. Monitor and interpret global regulatory requirements relevant to physiotherapy and medical equipment. Maintain regulatory compliance throughout the product lifecycle. Interface with regulatory agencies, notified bodies and external consultants. Ensure accurate and timely product registrations in target markets. Maintain up-to-date Device Master Files (DMF) and Technical Documentation. Support clinical evaluation and risk assessment documentation where required. Ensure products comply with applicable regulations, standards and guidelines Manage change notifications, renewals, amendments and post-market surveillance requirements. Support A for audits, CAPAs, internal documentation practices and inspections from regulatory bodies. Provide regulatory guidance to R&D, QA, Marketing during product development and changes. Review and approve labeling, packaging and promotional materials to ensure compliance. Collaborate with external consultants, legal teams or distributors for country-specific compliance. Monitor regulatory changes and industry updates across markets. Participate in external seminars, forums and internal training to build regulatory awareness. Supporting and enabling effective and efficient communication that results in operational excellence. Skills required: Degree in Biomedical Engineering, Pharmacy or related field. 36 years of regulatory experience in the medical device industry. Strong knowledge of regulatory frameworks (US FDA, EU MDR, CDSCO, ISO 13485). Experience with regulatory submissions and product registrations. Excellent technical data interpretation skills including problem solving Excellent oral and written communication skills with strong presentation skills Demonstrate subject matter and area expertise Excellent computer skills; Good knowledge of document management systems Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines