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Director of Quality and Regulatory Affairs
2 weeks ago
Responsibilities
Quality Management:
o Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.
o Set and achieve QMS Key Performance Indicators (KPIs) to drive ready compliance quality culture.
Regulatory Affairs:
o Develop regulatory strategies for new product development and market entry, ensuring compliance with FDA, CE, and other international regulatory requirements.
o Monitor and interpret regulatory developments and communicate implications to the executive team.
Leadership and Collaboration:
o Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization.
o Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure quality and regulatory considerations are integrated into all phases of product development and commercialization.
Training and Education:
o Develop and conduct training programs on quality and regulatory requirements for employees.
o Ensure all staff are informed about the latest regulatory changes and quality standards.
o Additional duties as assigned.
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Director of Quality and Regulatory Affairs
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