Senior Regulatory Affairs Specialist (Hyderabad)

Senior Regulatory Affairs Specialist (Hyderabad)

19 Aug
|
Medtronic
|
Hyderabad

19 Aug

Medtronic

Hyderabad

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team setting with all organizational departments. Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.
Responsibilities may include the following and other duties may be assigned:
Lead in development/maintenance of regulatory files, data, records, and reporting systems of systematic retrieval of information.
Prepare, review, file,



and support premarket documents for global registrations for assigned projects.
Provide requested regulatory data and documents to support tenders.
Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
Compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance.
Monitors and improves tracking/control systems.
May direct interaction with regulatory agencies on defined matters.
Develop Regulatory Strategies for new or modified products for assigned projects.
Monitor and provide information pertaining to impact of changes in the regulatory environment.
Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
Document, consolidate, and maintain oral and written communication with health authorities

📌 Senior Regulatory Affairs Specialist (Hyderabad)
🏢 Medtronic
📍 Hyderabad

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