Job Description Summary

Job Description

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

Excellent communication and organization skills

Excellent problem solving and analytical skills

Detail-oriented, with focus on accuracy and completeness

Ability 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

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

Working knowledge of ISO 13485 and 21 CFR 820 quality system requirements.

Experience with product development processes and design control.

Mentor/teach

Proven prior experience required 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.

Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint)

The Sr. Regulatory Affairs Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. They participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review design control documents and product labeling, and evaluate proposed device changes. The Sr. Regulatory Affairs Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.

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.

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.