Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist serves as the regulatory lead for assigned product portfolios, supporting market access, product lifecycle management, and regulatory compliance across India. The role works closely with commercial, operational, clinical, and global regulatory teams to execute regulatory strategies, maintain licenses, and deliver timely approvals that support business objectives and uninterrupted product availability.

Primary Responsibilities

• Manage product registrations, import licenses, renewals, and post-approval change submissions for medical devices in India.
• Develop and execute regulatory strategies supporting new product introductions and lifecycle management activities.
• Interface with regulatory authorities including Central Drugs Standard Control Organization (CDSCO), State Food and Drug Administration (FDA) authorities, Bureau of Indian Standards (BIS), Department of Telecommunications (DoT), and Customs authorities.
• Prepare, review, and submit regulatory documentation to support product approvals, license maintenance, and compliance requirements.
• Partner with Sales, Marketing, Supply Chain, Clinical Affairs, and Global Regulatory teams to support business priorities and market access objectives.
• Monitor submission timelines, approval status, and regulatory milestones to ensure delivery against commitments and key performance indicators.
• Provide regulatory guidance on compliance, product changes, and regulatory requirements impacting business operations.
• Maintain accurate regulatory records and support responses to regulatory queries, reviews, and inspections.

Required Qualifications

• Bachelor's degree OR Master's degree in Pharmacy, Biomedical Engineering, with relevant Regulatory Affairs experience in Medical Devices or Pharmaceuticals.
• Experience with product registrations, licensing, post-approval changes, and regulatory submissions.
• Knowledge of Indian Medical Device Rules and regulatory requirements administered by CDSCO and related regulatory authorities.
• Experience interacting with regulatory agencies and managing regulatory documentation throughout the product lifecycle.
• Ability to manage multiple regulatory projects and competing priorities.

Preferred Profile

• M.Pharm with Regulatory Affairs experience in the Medical Device industry.
• 6-10 years of experience within multinational Medical Device or Pharmaceutical organizations.
• Experience supporting multiple therapy areas and diverse product portfolios.
• Experience developing regulatory strategies and resolving complex regulatory challenges.
• Exposure to clinical trial regulatory activities and collaboration with global regulatory teams.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).