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?? or Master?? 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?? career portal: Apply Here Application Deadline: Open until filled