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 submissions, product registrations, and regulatory compliance activities for medical devices and healthcare products. The role involves preparing regulatory documentation, developing regulatory strategies, reviewing technical and clinical documentation, coordinating with global regulatory teams, supporting health authority interactions, and ensuring compliance with FDA, EU, and international regulatory requirements throughout the product lifecycle.
KEY RESPONSIBILITIES
Regulatory Submissions
Prepare, review, and submit regulatory documentation for global product registrations.
Support premarket submissions and marketing authorization activities.
Compile regulatory dossiers for license renewals and annual registrations.
Prepare documentation for product modifications and regulatory changes.
Ensure timely completion of regulatory submission activities.
Regulatory Strategy
Develop regulatory strategies for new and modified products.
Assess regulatory pathways for assigned projects.
Monitor changes in global regulatory requirements.
Evaluate regulatory impact of product and design changes.
Provide regulatory guidance to project teams.
Documentation & Compliance
Review pre-clinical and clinical documentation for regulatory submissions.
Author and update regulatory procedures and work instructions.
Maintain regulatory files, records, and document management systems.
Review product labeling, advertising, and promotional materials for compliance.
Ensure compliance with FDA, EU, and international regulatory standards.
Cross-Functional Collaboration
Collaborate with R&D, Quality, Clinical, Manufacturing, and Global Regulatory teams.
Coordinate with international regulatory affairs personnel.
Provide regulatory support during product development activities.
Communicate with health authorities on regulatory matters.
Support cross-functional regulatory initiatives.
Audits & Inspections
Participate in health authority inspections and notified body audits.
Support internal and external regulatory audits.
Review change control documentation for regulatory impact.
Maintain inspection-ready documentation.
Assist in resolving regulatory observations.
Continuous Improvement
Monitor evolving regulatory guidelines and industry trends.
Recommend improvements to regulatory processes.
Support regulatory intelligence initiatives.
Promote best practices within the regulatory function.
Maintain current knowledge of global regulatory requirements.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Pharmacy
Life Sciences
Medical Sciences
Biomedical Engineering
Mechanical Engineering
Electrical Engineering
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 submission experience.
US FDA and EU regulatory knowledge.
Product registration and lifecycle management.
Regulatory strategy development.
Health authority interaction experience.
Cross-functional project experience.
CERTIFICATIONS
Preferred
RAPS Regulatory Affairs Certification (RAC)
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Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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