Senior Regulatory Affairs Specialist

About the role

Medtronic, a global healthcare technology company, is looking for a Senior Regulatory Affairs Specialist in Nanakramguda. The role supports design and development control activities under regulatory requirements, works in a team environment with all departments, and prepares document packages for international regulatory submissions, internal audits and inspections.

Key responsibilities

• Prepare, review, file and support premarket documents for global registrations and compile materials for submissions, license renewals and annual registrations.
• Lead the development and maintenance of regulatory files, data, records and reporting systems, and set up a new process for entering new data in the Regulatory Information Management System.
• Advise on consistent interpretation of required data attributes and prepare regulatory data and documents to support tenders.
• Collaborate with business units and international regulatory affairs personnel to support marketing authorizations.
• Recommend changes to labelling, manufacturing, marketing and clinical protocols for regulatory compliance.
• Develop regulatory strategies for new or modified products and monitor the impact of regulatory changes.
• Communicate with regulatory agencies and health authorities, and authorise or review regulatory procedures and change control documents.

Required profile

• Bachelor's degree in medicine, mechanical, electrical, life sciences or another healthcare-related major.
• 7+ years of experience in a regulatory affairs role in the medical device or pharmaceutical industry.
• Ability to work independently with general supervision on moderately complex projects and to contribute to project milestones.

Nice to have

• Excellent written, organisational and communication skills.
• Flexible, team-oriented attitude, self-motivated and positive.

What we offer

• A competitive salary and a flexible benefits package.
• Eligibility for the Medtronic Incentive Plan (MIP).