Principal Specialist, Regulatory Affairs (Medical Device)

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Job Summary

This role is responsible for providing regulatory support for on-market products. You will independently plan, organize and execute, activities including 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, verification & validation.

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 cross functions research & development teams.

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: Design History File (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.

What you’ll bring

• Bachelor's 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 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

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.

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