Dynamics Group, Cleveland, Ohio
responsibility
- quality management:
- Develop, implement and maintain the company’s Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.
- Oversees internal and external audits to ensure compliance with regulatory requirements and company policies.
- Set and achieve QMS Key Performance Indicators (KPIs) to drive a compliant quality culture.
- Regulatory Affairs:
- Develop regulatory strategies for new product development and market entry while ensuring compliance with FDA, CE, and other international regulatory requirements.
- Prepare and submit regulatory submissions, including 510(k), PMA, and international submissions, as required.
- Monitors and interprets regulatory developments and communicates their impact to management.
- Leadership and collaboration:
- Lead and mentor the Quality and Regulatory Affairs team to foster a culture of quality and compliance across the organization.
- You will work with cross-functional teams including R&D, manufacturing and marketing to ensure quality and regulatory considerations are integrated into all stages of product development and commercialization.
- Acts as the main point of contact with regulatory and notified bodies and manages all communications and inspections.
- Training and Education:
- Develop and implement training programs for employees on quality and regulatory requirements.
- Ensure all staff are up to date with the latest regulatory changes and quality standards.
- Additional duties as assigned.
Requirements
A bachelor’s degree is required.
- Over 15 years of quality experience.
- Proven strong leadership skills with the ability to hire, coach and guide quality engineering professionals.
- The successful candidate will be from the medical device industry.
- Lean, Six Sigma, ASQ or similar certifications would be an advantage.
- Experience with new product development and approval through original product applications (CE Mark and FDA 510(k)).
- Experience in maintaining medical device quality systems and complaints (especially ISO 13485).
