Mgr ,Quality & Regulatory Affairs

Baxter International Inc.; Gurugram District; On-site; INR 800,000 - 1,600,000; Full time

Job summary

Baxter International Inc. in India is seeking regulatory professionals to support product registrations and life-cycle management for medical devices and pharmaceuticals.

You will engage with country authorities, manage change controls and recalls, and ensure labeling and import compliance across India and neighbouring markets.

We value courage, trust, and collaboration, offering a purpose-driven career and global opportunities.

Responsibilities

• Track submissions, responses & approvals for medical devices applications & Import and registration division on SUGAM portal
• Establish strong relationships with country regulatory authorities for technical and strategic discussions
• Monitor country regulatory changes and assess impact on current product portfolio
• Build strategies for regulatory changes and communicate to Global and country cross-functional teams
• Ensure product lifecycle management for all registered products in India and adjoining countries; manage labeling changes and local India-specific requirements
• Regulatory change control assessment and timely reporting of post-approval changes to authorities
• Timely filing of product recalls/complaints as per SOP
• Timely release of port consignments for commercialization to meet business demands
• Timely release of batches from NIB to support tender requirements
• Manage audits, regulatory inspections, or product recalls
• Participate in development or implementation of clinical trial protocols

Job description

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

• Tracking of online submissions, query responses & approvals for medical devices applications & Import and registration division applications on SUGAM portal
• Establish strong relationship with country regulatory authorities to facilitate technical and strategic discussions related to product.
• Monitoring of country regulatory changes and assessment per se their impact on current product portfolio.
• Build strategies for country regulatory changes and communicate to Global and country cross functional teams.
• Ensure product life cycle management for all registered products in India & adjoining countries. To ensure timely closure of all labelling changes (with global) per se India specific labelling requirements and creation of local labels with India specific requirements for devices prior to custom clearance and commercialization
• Responsible for change control assessment from regulatory perspective and timely reporting of post approval changes to respective regulatory authorities.
• Timely filing of product recalls/complaints notification as per SOP to regulatory agency.
• Responsible for timely release of port consignments (Air and Sea) for commercialization of product to meet business demands.
• Responsible for timely release of batches from NIB to support business to cater tender requirements.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• Participate in the development or implementation of clinical trial protocols

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.