Manager of Quality and Regulatory Affairs

Join Medicom as a Manager in Quality and Regulatory, where your leadership will enhance operational and regulatory compliance. This role combines strategic decision-making with team management.

You will lead the MML Quality and Regulatory division, focusing on quality assurance in production and compliance practices. With over a decade of experience in regulatory affairs, your role will involve developing effective quality processes that align with ISO 13485 and FDA regulations. Drive a risk-based approach while supporting the company's growth through continuous improvement initiatives.

Key Responsibilities:

• Manage MML Quality and Regulatory team effectively

• Drive risk-based quality compliance initiatives

• Mentor and develop quality assurance professionals

• Ensure compliance in Quality Governance and Operations

• Oversee product realization quality checks and validations

Requirements:

• Bachelor’s degree in a relevant technical field

• 10+ years in regulated medical device industry

• 5+ years in a leadership role

• Proven compliance leadership in ISO 13485

• Experience with digital quality metrics implementation

Shape the future of healthcare quality standards and regulations at Medicom.
#J-18808-Ljbffr