Job Information
DYNAMIX GROUP LLC Director of Quality and Regulatory Affairs in Cleveland, Ohio
Responsibilities
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- 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.
- 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.
- 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.
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.