Principal Specialist – Regulatory Affairs – Gurgaon, Haryana
Location: Gurgaon, Haryana, India
Job Type: Full-Time
Requisition ID: R36324
Posted: 22 Days Ago
About the Role:
Medtronic is hiring a Principal Regulatory Affairs Specialist to lead complex regulatory projects and initiatives. This is a senior-level individual contributor role with significant impact across compliance, strategy, and documentation functions. The position requires leadership in managing regulatory submissions, audits, and correspondence with health authorities, while also mentoring junior team members and influencing broader regulatory strategies.
Key Responsibilities:
Coordinate and prepare document packages for regulatory submissions, audits, and inspections across multiple business areas.
Compile and manage materials for license renewals, registrations, and other compliance filings.
Recommend and drive improvements in labeling, clinical protocol, marketing, and manufacturing to meet regulatory standards.
Lead interactions with regulatory agencies on defined matters to facilitate approvals and compliance.
Keep updated with evolving global regulatory guidelines and processes.
Monitor and improve internal tracking and control systems to ensure efficiency and data integrity.
Recommend strategic approaches to enable the earliest possible clinical trial and product approvals.
Coach and guide junior regulatory specialists, overseeing project deliverables and process improvements.
Work cross-functionally to integrate regulatory inputs into product development and compliance planning.
Qualifications & Experience:
Bachelor’s degree in B.Tech, B.Sc, B.Pharma, or BCA.
7–13 years of regulatory affairs experience, preferably in the medical device, pharmaceutical, or healthcare technology industry.
Mastery in regulatory documentation, audit preparation, and cross-border regulatory environments.
Excellent knowledge of project management principles, global regulatory strategies, and compliance systems.
Proven ability to handle moderately complex and undefined problems, driving actionable solutions independently.
Strong experience in stakeholder communication, regulatory negotiation, and team collaboration.
Work Environment & Expectations:
Recognized expert leading high-impact projects.
Operates with considerable autonomy, taking ownership of initiatives that influence product and process standards.
May serve as primary liaison with regulatory bodies and vendors.
Expected to mentor junior specialists and drive continuous improvement in regulatory frameworks.
Estimated Salary: ₹28 – ₹40 LPA (based on experience and market standards)
Gujarat :
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