Hiring.Camp

Mgr ,Quality & Regulatory Affairs (India & Singapore)

Baxter

·

1 week ago

Location
GURGAON - Gurgaon, India
Type
Full-time
Department
Legal
Source
Workday

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. 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.

Similar Jobs

30

Mgr-Quality

Marriott Hotels & Resorts · Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, MY

1 week ago

Mgr, Quality

Worthington Armstrong Venture · Westerville, OH, United States, US

3 weeks ago

Mgr-Quality

Marriott Hotels & Resorts · Khanh Hoa, Viet Nam, VN

3 weeks ago

Mgr, Quality

Facility 238 - Conifer Revenue Cycle Solutions · Phoenix, AZ, United States, US

3 weeks ago

Mgr, Quality

Facility 238 - Conifer Revenue Cycle Solutions · Glendale, AZ, United States, US

3 weeks ago

Mgr-Quality

Marriott Hotels & Resorts · Shanghai, China, CN

1 month ago

Mgr, Quality

Mksinst · Korea Jangan Gyeonggi-do, Korea, Republic of

1 month ago

Mgr Quality Engineering I

AM General · Mishawaka, IN

4 days ago

Mgr, Quality Management

Horizon · Hopewell, NJ, United States of America · Hybrid

1 week ago

Mgr, Quality Evaluation

American Academy of Pediatrics · Itasca, IL

1 week ago

Mgr Quality Assurance in the Plant

Jj · NL003 Einsteinweg 101, Netherlands · Hybrid

2 weeks ago

Mgr-Quality Laboratories, Engines EMEA

Rehlko · IT_Reggio Nell'Emilia, Italy · Onsite

2 weeks ago

Mgr, Quality & Regulatory Affairs (India & Singapore)

Baxter · GURGAON - Gurgaon, India

2 weeks ago

Mgr, Quality Engineering

Lam Research · Simpang Ampat, Penang,MY, MY

3 weeks ago

Mgr Quality 2

Northrop Grumman · Jacksonville, FL,US, US

4 weeks ago

Mgr Quality 2

Northrop Grumman · FLJA01, United States of America

4 weeks ago

Sr Mgr, Quality Assurance

Endo · India - Pudupakkam

1 month ago

Mgr - Quality I

Amcor · AF Pauls Valley OK, United States of America

1 month ago

Sr Mgr Quality Assurance

Renesas Electronics · Bayan Lepas, Penang, Malaysia · onsite

1 month ago

Mgr, Quality - Location: Kuala Lumpur

Lam Research · Kuala Lumpur, Federal Territory of Kuala Lumpur,MY, MY

1 month ago

Sr Mgr, Quality Engineering

CVS Health · Hartford-Farmington Ave Rogers, United States of America · Onsite

1 month ago

Mgr, Quality Assurance Engineering

Disney · IND - Bangalore - Ecoworld 6B - 7th Floor, India · Onsite

2 months ago

Product Engineering & Quality Mgr - Electrical

Worthington Armstrong Venture · Columbus, OH, United States

2 months ago

Mgr Quality-411

SESI Corp · Broussard, LA

4 months ago

MGR QUALITY CARE MGMT

Covenanthealth · Knoxville, TN, US

5 months ago

Quality Manager, Mgr

Fontana · Belvidere, 826 E MADISON ST, Belvidere, Illinois, United States of America

1 week ago

Quality Control, Mgr

Baxter · BR/SA1 - Bax Hosp-SP Plant, Brazil

1 week ago

Sr Mgr, QA/Quality Engineer, Device & Combination Products

Esperion Therapeutics · Ann Arbor, MI

2 weeks ago

Mgr, Plant Quality Systems II

Refresco Brand · Joplin, MO

1 month ago

Mgr, Logistics Quality

Lam Research · Bunyip North, VIC,AU, AU

2 months ago