Director Of Quality And Regulatory Affairs

Job Description
Responsibilities
Quality Management:
ODevelop, implement, and maintain the company’s Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.
OOversee internal and external audits to ensure compliance with regulatory requirements and internal policies.
OSet and achieve QMS Key Performance Indicators (KPIs) to drive ready compliance quality culture.
Regulatory Affairs:
ODevelop regulatory strategies for new product development and market entry, ensuring compliance with FDA, CE, and other international regulatory requirements.
OPrepare and submit regulatory filings, including 510(k), PMA, and international submissions, as required.
OMonitor and interpret regulatory developments and communicate implications to the executive team.
Leadership and Collaboration:
OLead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization.
OCollaborate 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.
OServe as the primary point of contact with regulatory bodies and notified bodies, managing all communications and inspections.
Training and Education:
ODevelop and conduct training programs on quality and regulatory requirements for employees.
OEnsure all staff are informed about the latest regulatory changes and quality standards.
OAdditional duties as assigned.