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Head of Quality and Regulatory Compliance
2 months ago
The Research Group is seeking a highly experienced professional to lead our Quality and Regulatory Affairs department. This role is critical in ensuring our products meet the highest standards of quality and comply with all regulatory requirements.
Key Responsibilities
Quality Management:
- Design, implement, and sustain the Quality Management System (QMS) aligned with ISO 13485 and other applicable standards.
- Manage both internal and external audits to confirm adherence to regulatory mandates and internal protocols.
- Establish and monitor QMS Key Performance Indicators (KPIs) to cultivate a culture of compliance and quality.
Regulatory Affairs:
- Formulate regulatory strategies for new product initiatives and market introductions, ensuring alignment with FDA, CE, and other global regulatory frameworks.
- Prepare and file necessary regulatory documents, including 510(k), PMA, and international submissions.
- Stay abreast of regulatory changes and relay pertinent information to the executive leadership.
Leadership and Collaboration:
- Guide and develop the Quality and Regulatory Affairs team, promoting a culture centered on quality and compliance across the organization.
- Work closely with cross-functional teams, including Research & Development, manufacturing, and marketing, to integrate quality and regulatory aspects throughout product development and commercialization.
- Act as the main liaison with regulatory authorities and notified bodies, overseeing all communications and inspections.
Training and Development:
- Create and deliver training sessions on quality and regulatory standards for all employees.
- Ensure that all personnel are updated on the latest regulatory developments and quality benchmarks.
- Perform additional responsibilities as assigned.
Qualifications
- A Bachelor's degree is required.
- Over 15 years of experience in Quality Management.
- Proven leadership capabilities with a track record of mentoring and developing Quality Engineering professionals.
- Experience in the Medical Devices sector is essential.
- Certifications in Lean, Six Sigma, ASQ, or similar methodologies are advantageous.
- Familiarity with new product development and regulatory approval processes, including CE Mark and FDA 510(k) submissions.
- Experience in maintaining medical device quality systems and handling complaints, particularly ISO 13485.
All information will be treated confidentially in accordance with EEO guidelines.
