Senior Quality Assurance and Regulatory Affairs Manager
4 weeks ago
Quality Assurance and Regulatory Affairs Leadership
We are seeking a highly experienced Senior Quality Assurance and Regulatory Affairs Manager to lead our quality and regulatory affairs functions. As a key member of our team, you will be responsible for developing, implementing, and maintaining our quality and regulatory programs and strategies.
Key Responsibilities:
- Develop and implement quality and regulatory strategies to ensure compliance with global market requirements.
- Partner with R&D, Marketing, and other groups to provide regulatory advice and guidance.
- Oversee the performance of internal and external audits.
- Review and maintain all departmental policies and procedures.
- Develop and implement training programs for employees.
Requirements:
- 10 years of QMS experience and demonstrated leadership experience.
- Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality System Inspection Techniques (QSIT); CFRs parts 210 &211.
- Strong understanding of global registration requirements.
- Experience with computer software validation (CSV) and implementation.
About Us:
We are Illusion Dental Laboratory, a leading provider of dental solutions. We are committed to delivering high-quality products and services that meet the needs of our customers.
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