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Full-time
bachelor degree
Posted 26d ago
Apply by Jul 24
~40 hrs/week
Responsibilities
Provide regulatory support for change assessments and prepare submission dossiers for drugs, biologics, and medical devices. Manage product life cycle activities and maintain regulatory systems and trackers while collaborating with cross-functional teams.
Requirements
Requires a Bachelor's degree in B.Tech with 0-2 years of relevant experience. Must have a sound understanding of ISO 13485, ISO 14971, and IEC 62304 standards along with strong technical skills in Microsoft Office.
Full 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.
Job Summary
As a Global Regulatory Affairs - Associate, you are responsible for providing regulatory support for change assessments, submission preparation for product registrations and submitting regulatory dossiers using various publishing tools for drugs, biologics & medical devices. Supporting various phases of product life cycle, generate capability towards fundamental global regulatory requirements and different regulatory pathways. Collaborating with cross-functional teams within the organization, including R&D, quality assurance and manufacturing departments. Ability to take ownership of tasks and deliver without supervision while using their expertise to seek help when necessary.
What you'll be doing
Engage with Global and Regional regulatory teams located across the globe to ensure regulatory activities are aligned to business needs for various drugs, biologics & medical devices submissions.
Supporting stakeholders in managing product registrations and ensuring high quality submissions to Regulatory Authorities.
Responsible for Regulatory Product Life Cycle Management Activities.
High Proficiency in Trackwise8 to handle Change Control Process and RIMS-Veeva Vault for Regulatory Submissions.
Tracking of status and progress of regulatory filings
Maintenance of Regulatory systems, trackers and databases.
What you'll bring
Bachelor’s degree in B. Tech from a reputed institution with 0-2 years of relevant experience.
Sound understanding of ISO 13485, ISO 14971, IEC 62304 standards.
Must possess strong analytical thinking, and excellent organizational and communication skills.
Candidate must be able to work in a team-oriented, fast-paced environment.
Strong technical skills (Excel, Microsoft word, Databases).
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.
Related keywords
Regulatory AffairsDrugsBiologicsMedical DevicesProduct Life Cycle ManagementTrackwise8RIMS-Veeva VaultISO 13485ISO 14971IEC 62304Change Control ProcessRegulatory SubmissionsB. TechGlobal Regulatory RequirementsQuality AssuranceR&D
For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world. We believe every person — regardless of who they are or where they are from — deserves a chance to live a healthy life, free from illness and full of possibility. At the intersection of progress and purpose is where we are redefining what it means to be a global medtech leader. It is where we are relentlessly pursuing healthcare transformation, fueled by our compassion for patients and providers and the challenges they face. It is where bold ideas meet the promise for meaningful change in the world around us. We are there, at every step of the journey, to help clinicians deliver the best care possible.
Offices: 1 Baxter Pkwy, Deerfield, Illinois 60015, US · 25212 IL-120, Round Lake, IL 60073, US · Calle Fernando Aranguren 830, Zapopan, JAL 45145, MX
Medical DevicesBiosurgeryAnestheticsand Pharmacy AutomationConsumerDeveloper PlatformMachinery ManufacturingHealth CareBiopharmaClinical Trials
How many Healthcare jobs are open in Bangalore, India right now?
There are currently 255 open healthcare positions in Bangalore, India listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Bangalore, India?
Companies currently hiring include Danaher, Solventum, Zimmer Biomet, Baxter International Inc., Vantive, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Bangalore, India?
Yes — 98 of the 255 open healthcare positions offer remote or hybrid work (17 remote, 81 hybrid).
How do I apply for Healthcare jobs in Bangalore, India?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.