Job Description Summary

This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. This position participates on cross-functional teams, leads the development of global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified bodies, reviews design control documents and product labeling, and evaluates proposed device changes. This position interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns and provides recommendations to minimize risk.

Job Description

Job Responsibilities

Represents Regulatory Affairs on product development teams to support new product
development and change control to ensure US, EU, and other global regulatory requirements are
met
Evaluates medical device regulations and leads development of global regulatory strategies to
bring products to market
Reviews and approves design control documentation and product labeling in consideration of US,
EU, and other global regulatory requirements
Authors FDA submissions, EU technical files, and other regulatory documents for submission to
regulatory bodies for product review and approval
Point of contact for FDA, EU notified bodies, and other regulatory agencies on submissions and
other issues
Independently reviews product changes to ensure regulatory compliance, including assessment of
impact to US and CE Mark and prepares resulting notifications
Communicates changes to global regions and supports preparation of global notifications as
needed
Understands fundamental global regulatory requirements and different regulatory pathways
Stays informed of new regulations and changes to existing regulations and communicates to
project teams
Maintains regulatory databases and systems
Supports regulatory body audits, CAPAS, and other compliance activities
Reviews advertising and promotional material
Participates and leads training related to areas of expertise
Mentor other regulatory colleagues
.This is not intended to be an all-inclusive listing of duties. Other job-related duties may be required.

Education and Experience

This position requires:
Bachelor's degree or higher, preferably in a scientific discipline
Master's degree in Regulatory Affairs preferred
Regulatory Affairs Professional Society (RAPS) certification preferred
4-6 years Regulatory Affairs experience in the medical device industry
Experience working with FDA, EU notified bodies, and other regulatory agencies
Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and
submissions
Proven experience owning and managing the end-to-end process of authoring, submitting and
obtaining regulatory approvals/clearances (510(k)s), including addressing and responding to
deficiencies from regulatory agencies
Experience with product development processes and design controls

Knowledge and Skills

Excellent written and verbal communication skills
Excellent problem solving and analytical skills
Detail-oriented, with a focus on accuracy and completeness
Excellent organization skills: able to manage multiple tasks and meet timeline commitments
Ability to work in a team-oriented, fast-paced environment
Demonstrated ability to analyze, interpret, review, and summarize scientific, technical, and
regulatory information
Comprehensive understanding of global medical device regulations, with in-depth knowledge of
US and EU requirements
Knowledge of product development and medical device quality system regulations
Ability to mentor and teach other regulatory associates
Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint)

Required Skills

Optional Skills

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift

Senior Regulatory Affairs Specialist