Quality & Regulatory Manager
We are seeking a highly experienced Quality & Regulatory Manager to lead our Quality & Regulatory Department, supporting the design and manufacture of medical devices in a customer-facing contract design and manufacturing organization.
The successful candidate will have ownership of the ISO13485/21CFR820 compliant Quality Management system, ensuring compliance with applicable standards and regulations. They will be responsible for quality oversight, driving successful completion of design and manufacturing projects, and coordinating activities to meet company goals.
The Role:
Provide leadership in implementing quality policies and fostering a high-performance culture through engineering design and manufacturing operations.
Develop quality strategy aligned with business and growth objectives.
Day-to-day management of quality function, leading customer-facing quality discussions, and implementing quality plans and agreements.
Participate in internal and external audits, guiding internal teams on industry best practices.
Plan and grow quality teams and functions to meet future requirements.
Monitor and manage CAPAs and customer complaints, taking ownership of corrective actions.
Stay current with external and internal quality systems standards and requirements.
Responsibilities:
Overall responsibility for regulatory compliance, acting as Management Representative for the Quality Management System.
Provide clear regulatory advice and guidance to the company and its customers, highlighting updates to regulatory requirements.
Establish and maintain effective procedures for quality and risk management processes.
Develop and oversee all aspects of the Quality Systems to ensure compliance with standards, regulations, and company needs.
Provide overall leadership to the broader team and other functions, fostering a diverse and entrepreneurial environment that enables all participants to contribute to their fullest potential.
Requirements:
Bachelor's degree in Science, Engineering, Quality Management, or related fields. Masters degree preferred.
Minimum of 8 years of experience in the Medical Device industry.
Experience working with Electromechanical based Class 2 medical devices an advantage.
Working knowledge of regulations and standards (e.g., 21CFR210, ISO 13485, MDD, MDR, etc.) with experience in executing Quality strategies.
Skills:
Excellent communications skills.
Ability to drive a culture of Quality Systems compliance and accountability.
Excellent analytical and decision-making skills.
Possess a flexible, pro-active approach to problem-solving, be an adept negotiator, and apply risk-based decisions.
Ability to develop and maintain strong collaborative relationships with all functional departments of the organization along with the Customer and Supplier base.