Director of Quality & Regulatory Affairs

Position Summary

The Director of Quality & Regulatory Affairs is an Exempt/Full-Time position and will lead the development, implementation, and management of quality assurance and regulatory compliance programs. This role is crucial for ensuring that our products meet all necessary regulatory standards and that our quality management system (QMS) supports our commitment to excellence. The ideal candidate will have extensive experience in quality and regulatory affairs within the medical technology or healthcare industry, along with a proven ability to navigate complex regulatory environments.

Responsibilities/Duties

Quality Management:

● Develop, implement, and maintain the company’s Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards

● Oversee internal and external audits to ensure compliance with regulatory requirements and internal policies

● Set and achieve QMS Key Performance Indicators (KPIs) to drive ready compliance quality culture

● Lead continuous improvement initiatives to enhance product quality and operational efficiency

● Ensure timely resolution of quality issues and non-conformances

Regulatory Affairs:

● Develop regulatory strategies for new product development and market entry, ensuring compliance with FDA, CE, and other international regulatory requirements

● Prepare and submit regulatory filings, including 510(k), PMA, and international submissions, as required

● Monitor and interpret regulatory developments and communicate implications to the executive team

● Maintain regulatory documentation and ensure all records are accurate and up-to-date

Leadership and Collaboration:

● Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization

● 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

● Serve as the primary point of contact with regulatory bodies and notified bodies, managing all communications and inspections

Training and Education:

● Develop and conduct training programs on quality and regulatory requirements for employees

● Ensure all staff are informed about the latest regulatory changes and quality standards

● Additional duties as assigned. 

Minimum Qualifications, Education, and Experience Required

Education and Experience 

● Bachelor’s degree and at least 15 years’ quality and regulatory experience working with medical devices (preferably class II and class III); advanced degree preferred

● Strong leadership and communication skills

● Experience with new product development and approval with original product submissions (CE Mark and FDA 510(k))

● Experience with maintaining medical device quality systems and complaints, specifically ISO 13485

● Lean, Six Sigma, ASQ or similar certification beneficial

● Proven track record of successful regulatory submissions and maintenance of regulatory compliance

● Strength in data analysis, trending, and forecasting of metrics

Abilities

● Ability to work on complex problems and business processes in which the analysis of situations and/or data frequently requires an in-depth evaluation of multiple, interdependent factors and professional judgment

● Perform “hands-on” quality and regulatory activities

● Flexibility and ability to self-start on new challenges, problem-solving with minimal supervision

● Ability to work efficiently on multiple tasks with deadlines in a small company where job duties/priorities may change

● Capable of working in a multifunctional team with members of varying education and experience levels

● Creative/innovative, able to rapidly problem-solve and work well given typical project schedules

Work Conditions:

Work is performed primarily in a standard office environment.  Essential functions require sufficient physical ability and mobility to work in an office setting; to stand or sit for prolonged periods of time; to occasionally bend, kneel and reach; to lift, carry, push/pull light to moderate amounts of weight; to operate office equipment that may require fine motor coordination (i.e., use of a keyboard).  Reasonable accommodations may be made when an employee has a qualified disability but can still perform the essential functions of the job (without creating an undue hardship).