Mgr ,Quality & Regulatory Affairs

Baxter

Job Location:

Gurgaon - India

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou 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. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.

Required Experience:

Manager

This is whereyour work makes a difference.At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 ...