- Leadership opportunity in terrific Medical Device Manufacturer
- Fully remote flexibility
About Our Client
Our client is a global leader in Vein technology. The have a very specialized niche and have grown steadily in sales over the last few years. They now have an opening in their leadership team to oversee Quality.
The key responsibilities of the Director of Quality & Regulatory are
- Maintain Quality System to ensure that the company is in compliance with all Regulatory and ISO 13485 requirements and certifications. Company operates in 3 key sites and has 3 key contract manufacturers as well as in-house manufacturing.
- Manage the Company's CAPA program to assure CAPAs are properly generated, and that corrective or preventative actions are identified, and effectiveness checks successfully completed in a time frame consistent with Company policy. Assure that the Corrective and Preventive Action Program and Audit Program comply with the Company's quality management system. The candidate will keep management advised of the status of these programs.
- Lead internal and external audits; assess operations to assure compliance to all applicable regulations and standards. Assist with any third party regulatory audits.
- Be internal subject matter specialist for regulatory strategy and implementation of filings and maintenance of approvals, trouble shooting, and regulatory authority interaction for product line.
- Manage worldwide regulatory program
- Maintain regulatory resource database with regulatory correspondences and documents.
- Keep Senior Management informed of regulatory status of products and significant regulatory issues and update them about new developments.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
The successful Director of Quality & Regulatory will have the following:
- 10+ years of senior-level in an FDA domestic quality and regulatory and international ISO/CE compliance experience.
- Ability to oversee quality and regulatory compliance duties of a Class 1 and Class 2/2A Medical Devices.
- Bachelors required in a scientific or technical field required; Advance degree preferred.
What's on Offer
The company offers a competitive base, bonus, and benefits package. They also can offer fully remote working flexibility.