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 teams.

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

This position is based out of Bangalore and reporting to the Manager - Systems - Patient Support Systems and Global Surgical Solutions divisions. You will need to work collaboratively with RD and cross functions.

What you ll be doing

- 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
- 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.

What you ll bring

- Bachelors Degree with 12+ years or master s 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 development, FDA Regulations and MDR.
- Strong interpersonal skills with the ability to collaborate with others in a team workplace
- 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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Principal Specialist, Regulatory Affairs (Bengaluru)
🏢 BAXTER
📍 Bengaluru