Regulatory Affairs Specialist
Company: Medtronic
Location: Hyderabad, India
Department: Regulatory Affairs
Job Type: Full-Time
Work Mode: Flexible Work Arrangement
JOB OVERVIEW
The Regulatory Affairs Specialist is responsible for supporting global regulatory activities for medical devices and healthcare products by preparing regulatory submissions, developing regulatory strategies, reviewing technical documentation, and ensuring compliance with international regulatory requirements. The role involves collaborating with cross-functional teams, supporting product registrations, managing regulatory documentation, participating in audits and inspections, and maintaining regulatory compliance throughout the product lifecycle.
KEY RESPONSIBILITIES
Regulatory Submissions
Prepare, review, and submit regulatory dossiers for global product registrations.
Support premarket submissions and marketing authorization activities.
Compile documentation for license renewals and annual registrations.
Prepare regulatory documents for product modifications and design changes.
Ensure timely submission of regulatory deliverables.
Regulatory Strategy
Develop regulatory strategies for new and modified medical devices.
Evaluate regulatory pathways for assigned projects.
Monitor changes in global regulatory requirements.
Assess the regulatory impact of design and product changes.
Provide regulatory guidance to cross-functional project teams.
Documentation & Compliance
Review pre-clinical and clinical documentation for regulatory submissions.
Author and update regulatory procedures, SOPs, and work instructions.
Maintain regulatory files, records, and document management systems.
Review labeling, promotional materials, and advertising for regulatory compliance.
Ensure compliance with FDA, EU MDR, and applicable international regulations.
Cross-Functional Collaboration
Collaborate with R&D, Clinical, Quality, Manufacturing, and Global Regulatory teams.
Coordinate regulatory activities with international business units.
Support health authority communications and regulatory correspondence.
Provide technical regulatory consultation to project teams.
Participate in cross-functional product development activities.
Audits & Inspections
Participate in health authority inspections and notified body audits.
Support regulatory compliance during internal and external audits.
Assist in regulatory assessments for change control activities.
Ensure audit readiness through proper documentation.
Address regulatory observations and corrective actions when required.
Continuous Improvement
Monitor regulatory trends and evolving global requirements.
Recommend improvements to regulatory processes.
Support regulatory intelligence initiatives.
Contribute to departmental process optimization.
Maintain current knowledge of regulatory guidelines and industry best practices.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Life Sciences
Pharmacy
Biomedical Engineering
Mechanical Engineering
Electrical Engineering
Medical Sciences
Healthcare-related discipline
EXPERIENCE REQUIREMENTS
Required
4–7 years of Regulatory Affairs experience in the Medical Device and/or Pharmaceutical Industry.
Preferred
Medical device regulatory affairs experience.
Global regulatory submissions experience.
US FDA and EU MDR regulatory knowledge.
Product registration and lifecycle management experience.
Regulatory strategy development.
Health authority interaction experience.
Cross-functional project experience.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Berlin |Baden-Wurttemberg :
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Cork | Dublin | Limerick | Waterford |Ulster :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
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Canada |Quebec :
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Zaventem |South America :
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Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Manila |Croatia :
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Tallinn |Hà Nội :
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