Job Title: Senior Regulatory Affairs Specialist
Location: Hybrid, Nanakramguda, Hyderabad, India
Time Type: Full Time
Posted On: Today
Job Requisition ID: R23060
Job Description
At Medtronic, you can embark on a lifelong career of exploration and innovation while championing healthcare access and equity for all. Join us in breaking down barriers to innovation in a more connected and compassionate world.
A Day in the Life
In this exciting role as a Senior Regulatory Affairs Specialist, you will be responsible for developing and implementing compliant regulatory processes within the Regulatory organization.
Key Responsibilities
Serve as a Subject Matter Expert (SME) to ensure appropriate coordination and advise on the consistent interpretation of required data attributes.
Stay updated with regulatory procedures and changes.
Provide regulatory data and documents to support tenders.
Lead the development and maintenance of regulatory files, data, records, and reporting systems for the systematic retrieval of information.
Prepare, review, file, and support premarket documents for global registrations for assigned projects.
Collaborate with business units and international regulatory affairs personnel to support marketing authorizations.
Prepare document packages for international regulatory submissions, internal audits, and inspections.
Compile all materials required for submissions, license renewals, and annual registrations.
Recommend changes for labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance.
Monitor and improve tracking/control systems.
Direct interaction with regulatory agencies on defined matters.
Develop regulatory strategies for new or modified products.
Monitor the regulatory environment for changes and their impact.
Communicate with regulatory agencies on administrative and routine matters.
Document, consolidate, and maintain oral and written communication with health authorities.
Prepare internal documents for modifications to devices.
Author and/or review regulatory procedures and update as necessary.
Review change control documents and assess regulatory impact for external and internal documents.
Qualifications
Minimum Qualifications
Bachelor’s degree in Medical, Mechanical, Electrical Life Sciences, or other healthcare-related majors.
7+ years of experience in a Regulatory Affairs role in the medical device and/or pharmaceutical industry (a mix is preferred).
Ability to work independently with general supervision on larger, moderately complex projects.
Contributes to the completion of project milestones and recommends process enhancements.
Excellent communication skills, with the ability to establish credibility with internal and external stakeholders.
Ability to manage projects to completion while adhering to timelines.
Highly organized, detail-oriented, and efficient, with the ability to work well under pressure.
Nice to Have
Knowledge and experience with US and global regulatory affairs.
Experience working with cross-functional teams.
RAPS Regulatory Affairs Certification (RAC).
About Medtronic
Medtronic is at the forefront of global healthcare technology, addressing the most challenging health problems with innovative solutions. Our mission—to alleviate pain, restore health, and extend life—unites our team of 95,000+ passionate individuals. We are engineers at heart, pushing ambitious ideas to create real solutions for real people.
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. We recognize the contributions of our employees and provide resources and compensation to support them at every stage of their career.
Gujarat :
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