Medtronic Hiring Regulatory Affairs Specialist in Hyderabad

Medtronic, a global leader in medical technology, is seeking a Regulatory Affairs Specialist to join its team in Nanakramguda, Hyderabad. This role is crucial for ensuring compliance with global regulatory standards within the medical device and pharmaceutical industry.

Job Description & Responsibilities

The Regulatory Affairs Specialist will be responsible for a range of tasks critical to Medtronic’s compliance and document management processes. Key responsibilities include:

Regulatory Liaison: Working with various organizational units to ensure the accurate application of regulatory processes and data attribute assignment.
Document Conversion: Converting technical documents into Global Submission Summary Documentation (GSSD).
e-BOM Creation: Creating e-BOM (electronic Bill of Materials) structures in CAP Agile for GSSD.
Process Improvement: Streamlining processes, potentially through the use of Artificial Intelligence.
Compliance Monitoring: Monitoring and ensuring compliance with multiple Quality Management Systems and staying updated on regulatory procedures and changes.

Candidate Profile

Education: A Bachelor’s degree in Medical, Mechanical, Life Science, or another healthcare-related major is required.
Experience: Candidates should have 4-7 years of experience in a Regulatory Affairs role within the medical device and/or pharmaceutical industry.
Work Style: The ideal candidate will be able to work independently with general supervision on moderately complex projects, contribute to project milestones, and suggest enhancements to systems and processes.
Communication: Strong internal communication skills are necessary, with the ability to share information, status, and issues to support decision-making.
Working Hours: Flexibility in working hours is required, as some times will involve working in the US EST time zone.

Desirable Skills and Qualifications

Knowledge and experience in US and global regulatory affairs.
Experience with cross-functional teams, problem-solving, and project management.
Strong verbal and written communication skills.
Highly organized, detail-oriented, and efficient team player.
RAPS Regulatory Affairs Certification (RAC) is a plus.

Application Details

Location: Nanakramguda, Hyderabad
Industry Type: Pharma/Healthcare/Clinical Research
Application End Date: October 20, 2025

This is an excellent opportunity for experienced regulatory affairs professionals to contribute to meaningful innovations at a leading global medical technology company.