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.

How to Apply?

Interested candidates can apply directly through Medtronic’s career portal: 👉 Apply Here

🕒 Application Deadline: Open until filled