Principal Specialist - Regulatory Affairs

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Job Title: Principal Specialist / Engineer – Regulatory Affairs

For us, working at Baxter is not just a job—it’s a calling. Our mission to save and sustain lives unites us.

We are driven not by what will be easy, but what will transform global healthcare for generations to come. Together, we create a place where we are happy, successful and inspire each other as we pursue rewarding careers.

We’re grateful you’re interested in continuing your career journey with Baxter. This is where your purpose accelerates our mission and make a positive impact on millions of people around the world. 

JOB SUMMARY: 

This role is responsible for providing regulatory support for on-market products.  You will be independently Plan, Organize and Execute, activities include change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams.

You will help accelerate the design and development cycle by collaborating across cross functional team.

Will be guiding, supporting and mentoring the team who are part of engineering design, development, and V&V.

This position is based out of Bangalore and reporting to the Manager – Systems - Patient Support Systems and Global Surgical Solutions divisions.

Essential Duties and Responsibilities:

•  Review and provide regulatory impact assessments for changes

• Support global submission deliverables for product variation submissions

• Responsible for working with other parts of the regulatory organization to achieve desired results.

• Execute global plans and regulatory submission deliverables for sustaining variations

• Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results

• Ensure identified standards and content requirements are met for regulatory submissions

• Timely, actively support query responses

• Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements

• Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).

• Maintain regulatory files in a format consistent with requirements

• Tracking of status, quality/compliance and progress of regulatory documentation

• Review, edit and proofread regulatory documentation

• Work closely with product development, clinical, and marketing teams to gain required information for new product submissions and provide regulatory input to project teams as required (Example: DHF remediation, labeling guideline)

• Assist with the review of documents, including risk analysis, FMEA, reports, labeling, advertising, promotion and marketing literature

• Assist with document control, including document review, approval, archiving, maintenance of document list, and working with other functional groups on development of new processes or procedures

• Maintain regulatory files in a format consistent with requirements

• Assist with the writing and coordination of regulatory submissions for both, developed and emerging countries/regions, including original IDE, original PMA, and 510(k) submissions and supplements, EU Design Dossiers and Technical Files, Canadian Device License Applications, etc.

Your Team:

This position will be reporting to the Manager – Systems - Patient Support Systems and Global Surgical Solutions divisions. This position does not have any direct reports. You will need to work collaboratively with R&D and cross functions.   

Your Location:

The role is in Baxter R&D facility in Bangalore India.   

What You’ll Bring:

• Bachelor's Degree with 12+ years or Masters with 8+years’ experience in Bio-medical engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Mechanical Engineering, Industrial Engineering or related field 

• Experience, practitioner in basic engineering function of Medical device

• Experience in Medical Device development, FDA Regulations and MDR. 

• Strong interpersonal skills with the ability to collaborate with others in a team environment 

• Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards. 

• Able to deliver on multiple projects simultaneously 

  • Knowledge of regulations and ability to communicate and apply,

  • Ability to identify compliance risks and escalate, when necessary,

  • Excellent verbal and written English communication skills, suitable for multi-location working relationships,

  • Demonstrated teamwork and collaboration skills,

  • Aptitude for Mindfulness and attention to detail,

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.

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