Lead Regulatory Affairs Specialist

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

P TCI Role - JG 3C)

Job Responsibilities:

• Represents Regulatory Affairs on product development teams to support 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

Education and Experience:

• Bachelor's degree or higher, preferably in a scientific discipline
• Master's degree in Regulatory Affairs preferred
• Regulatory Affairs Professional Society (RAPS) certification preferred
• 7- 12 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