Guide regulatory and licensing decision-making processes based on relevant regulatory requirements of medical devices.
Complete and maintain regulatory filings by leading internal groups, collaborating with external groups, providing direction to obtain supporting technical information, and implementing focused solutions for identified changes and challenges.
Oversee the communication of regulatory requirements to internal or external customers.
Lead communication with critical regulators to respond to non-conformances, deficiencies, and questions.
Develop and implement processes and procedures to maintain regulatory compliance related to medical device pre- and post-market activities involving regulatory, R&D, quality and medical affairs.
Monitor changes in the regulatory and legislative environment.
Recommend regulatory pathways, strategies, solutions, and future actions for specific and...
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