Senior Regulatory Affairs Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

The Regulatory Affairs function is responsible for enabling patient access to Medtronic therapies by ensuring products meet applicable regulatory requirements throughout their lifecycle. This role supports Medtronics medical device portfolio in India partnering with global and local stakeholders to manage regulatory submissions product registrations license maintenance post-approval changes and compliance activities across multiple therapy areas.

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

• Bachelors degree OR Masters 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

• 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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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.