Director of Quality and Regulatory

Newton Permanent USD160,000 - USD180,000
  • 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.

Job Description

The key responsibilities of the Director of Quality & Regulatory are

Quality

  • 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.



Regulatory

  • 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.

Contact
Daniel Hall
Quote job ref
JN-042022-5416584

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Healthcare / Pharmaceutical
Location
Newton
Contract Type
Permanent
Consultant name
Daniel Hall
Job Reference
JN-042022-5416584