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

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

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.

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

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.

Requirements

A Bachelor’s degree required.

15 + years of Quality experience.

A strong history of leadership skills with the ability to hire, mentor and guide Quality Engineering professionals.

The successful candidate will come from the Medical Devices industry.

Lean, Six Sigma, ASQ or similar certification beneficial.

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.

All your information will be kept confidential according to EEO guidelines.