Regulatory Affairs Specialist

Regulatory Affairs Specialist at Medtronic in India. Responsibilities include preparing, reviewing, filing, and supporting premarket documents for global registrations for assigned projects; collaborating with business units and international regulatory affairs personnel to support marketing authorizations; reviewing preclinical and clinical protocols for submissions; developing regulatory strategies for new or modified products; monitoring regulatory environment changes; maintaining communications with health authorities; compiling materials for submissions, license renewals, and annual registrations; participating in inspections and audits; authoring or reviewing regulatory procedures; reviewing change control documents for regulatory impact; maintaining regulatory files and reporting systems; reviewing promotional material, advertising, and labeling for regulatory compliance; ensuring compliance for clearance and approvals of OU developed materials. Requires a Bachelor’s degree in a healthcare-related field and 4-7 years of regulatory affairs experience in medical device or pharmaceutical industries; strong written and spoken English, organizational skills, and ability to work under pressure; knowledge of India, US FDA, and EU regulations; RAC is a nice-to-have. The posting emphasizes cross-functional teamwork, project management, and a detail-oriented approach to regulatory documentation.