Lead Regulatory Affairs Specialist

P3-14314 - (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:

• Bachelors degree or higher, preferably in a scientific discipline
• Masters 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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