Work from Home Regulatory Affairs Specialist Hiring Medtronic

Work from Home Regulatory Affairs Specialist Hiring Medtronic Join Medtronic as a Regulatory Affairs Specialist | Hybrid Opportunity Are you an experienced Regulatory Affairs Specialist looking for a career opportunity with a global healthcare leader? Medtronic is currently hiring for a Regulatory Affairs Specialist (Level II) in Hyderabad, India, with the flexibility of a hybrid work-from-home arrangement. This is a fantastic opportunity to work with a renowned medical technology company and contribute to regulatory compliance and innovation in healthcare. Job Details • Company: Medtronic • Position: Regulatory Affairs Specialist – II • Vacancies: 2 • Work Type: Hybrid (Work from Home + Office) • Location: Nanakramguda, Hyderabad, India • Employment Type: Full-time Roles & Responsibilities As a Regulatory Affairs Specialist, you will: • Support design and development control activities with regulatory strategies and requirements. • Prepare, review, file, and support premarket regulatory documents for global product registrations. • Collaborate with business units and international regulatory teams to obtain marketing approvals. • Review pre-clinical and clinical protocols to ensure compliance with regulatory standards. • Develop regulatory strategies for new or modified medical devices. • Maintain oral and written communication with health authorities. • Participate in regulatory inspections and audits. • Review and assess change control documents to determine regulatory impact. • Ensure compliance with India CDSCO, US FDA, and EU MDR regulatory frameworks. Qualifications & Experience Required Minimum Qualifications: Education: Bachelor’s or Master’s degree in: • Life Sciences (BSc, MSc) • Pharmacy (B. Pharm, M. Pharm) • Medical, Mechanical, Electrical Engineering Experience: • 4-7 years of regulatory affairs experience in the medical device or pharmaceutical industry • Strong knowledge of India CDSCO, US FDA, and EU MDR regulations • Experience with regulatory submissions and product approvals • Excellent written and verbal communication skills Preferred Qualifications: • Global regulatory affairs knowledge and experience. • Experience working with cross-functional teams. • Strong problem-solving and project management skills. • RAPS Regulatory Affairs Certification (RAC) is a plus. • Ability to work under tight deadlines and pressure. [caption id="attachment_121768" align="aligncenter" width="1200"] Work from Home Regulatory Affairs Specialist Hiring Medtronic | Apply Now[/caption] How to Apply? Interested candidates can apply directly through Medtronic’s career portal: Apply Here Application Deadline: Open until filled Apply Job!