Regional QARA Manager (Medical Device)

Job Description

• 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...