Sr. Regulatory Affairs Specialist
Company: Medtronic
Location: Gurgaon, Haryana, India
Department: Regulatory Affairs
Job Type: Full-Time
Work Mode: Flexible Work Arrangement
JOB OVERVIEW
The Sr. Regulatory Affairs Specialist is responsible for leading regulatory submission activities and ensuring compliance with global regulatory requirements for medical devices and healthcare products. The role involves preparing regulatory submissions, managing product registrations and license renewals, supporting audits and inspections, developing regulatory strategies, monitoring regulatory changes, and collaborating with cross-functional teams to achieve timely product approvals. The position also provides technical guidance, mentors junior colleagues, and contributes to process improvements and regulatory compliance initiatives.
KEY RESPONSIBILITIES
Regulatory Submission Management
Prepare, coordinate, and submit regulatory documentation for global product registrations.
Compile submission packages for new product approvals, renewals, and annual registrations.
Ensure regulatory submissions comply with applicable global regulations and standards.
Maintain complete and accurate regulatory documentation.
Support timely submission of regulatory dossiers.
Regulatory Compliance
Ensure compliance with applicable global regulatory requirements.
Recommend changes to product labeling, manufacturing processes, marketing materials, and clinical protocols.
Monitor evolving regulatory requirements and communicate their impact.
Support internal audits and external regulatory inspections.
Maintain regulatory compliance throughout the product lifecycle.
Regulatory Strategy
Develop regulatory strategies to support timely product approvals.
Recommend approaches for clinical trial application submissions.
Assess regulatory risks associated with product changes.
Support lifecycle management activities for regulated products.
Contribute to regulatory planning for new and existing products.
Cross-Functional Collaboration
Work closely with Quality, Clinical, Manufacturing, Marketing, and R&D teams.
Coordinate regulatory activities across multiple functional groups.
Provide regulatory guidance during product development.
Support cross-functional project execution.
Collaborate with internal and external stakeholders.
Regulatory Agency Interaction
Communicate with regulatory authorities regarding assigned submissions.
Respond to regulatory queries and information requests.
Support agency inspections and compliance activities.
Maintain professional relationships with regulatory bodies.
Coordinate follow-up activities related to regulatory approvals.
Process Improvement
Monitor and improve regulatory tracking and control systems.
Identify opportunities to enhance regulatory processes.
Support implementation of process improvements.
Develop recommendations to improve submission efficiency.
Contribute to continuous quality improvement initiatives.
Project Leadership
Independently manage regulatory projects and deliverables.
Mentor and coach junior regulatory professionals.
Review work completed by lower-level specialists.
Support project planning and execution.
Ensure timely completion of assigned regulatory activities.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in one of the following:
Pharmacy (B.Pharm / M.Pharm)
Life Sciences
Biotechnology
Biomedical Engineering
Medical Devices
Biological Sciences
Healthcare
Or another relevant scientific discipline
Preferred
Master's Degree in a relevant scientific discipline
Regulatory Affairs Certification (preferred)
EXPERIENCE REQUIREMENTS
Required
Minimum 4 years of relevant Regulatory Affairs experience with a Bachelor's degree
OR
Minimum 2 years of relevant experience with an Advanced Degree
Preferred Experience
Medical Device Regulatory Affairs
Product Registration
Global Regulatory Submissions
Regulatory Compliance
Clinical Trial Applications
Regulatory Strategy Development
License Renewals
Internal & External Audits
Cross-functional Project Management
Regulatory Agency Interactions
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