REPORTS TO:               Vice President, Operations

SUPERVISES:                 Quality Department

 

SYNOPSIS OF POSITION:

This position responsible for creation, implementation, and maintenance of the Quality System processes, in compliance with FDA 21CFR, various U.S. and international Quality System regulations including 21 CFT Part 820, and ISO 13485. Manages all aspects of quality and regulatory compliance. Corresponds with FDA and EU notified bodies. Prepares and maintains international product registrations, facility establishment registrations, and device listings. Maintains regulatory files, consistent with state, federal and international regulatory requirements. Acts as Management Representative in reporting to management on performance measures for quality improvements and compliance. Provides knowledge and support to the company to enable company to operate within regulatory guidelines. 

 

ESSENTIAL FUNCTIONS:

 

  • Develops regulatory strategies for U.S. and Canadian markets.
  • Serves as FDA and international regulatory body first point-of-contact.
  • Manages and responds to FDA and regulatory agencies audits.
  • Completes annual registrations and submissions.
  • Reviews and interprets regulatory rules as they relate to company products and processes. Sets up Quality System policies and procedures to ensure compliance with FDA and various international requirements.
  • Conducts ongoing company-wide trainings on FDA and ISO requirements.
  • Assesses need for regulatory registrations and acts accordingly.
  • Responsible for Document Control process and the efficient control of all documentation required by regulatory agencies.
  • Maintains Design History Files.
  • Sets-up and oversees inspection and Device History Records activities.
  • Defines needed quality metrics and coordinates data collection from various functions.
  • Performs Management Reviews and advises management of any product or process related issues and makes recommendations for improvements.
  • Plans and manages internal audit activities and coordinates audit corrective actions.
  • Manages the CAPA process and ensures corrective actions are established and root-cause elimination is completed for identified issues.
  • Manages the Complaint Handling process and Medical Device Reporting activities.
  • Manages the Nonconforming Material process. Responsible for the administration and disposition of nonconforming materials.
  • Administers and manages supplier qualification activities and monitors suppliers’ performance.
  • Travels to vendors, trade shows and between facilities, possibly overseas.  

 

ADDITIONAL RESPONSIBILITIES

 

  • Stays current with various quality compliance and regulatory guidelines, standards, and regulations.
  • Identifies potential issues and minimizes regulatory risks through creative problem solving.
  • Additional duties as assigned.

 

EDUCATION & EXPERIENCE REQUIREMENTS:

 

  • Minimum of 10 years of Quality Management, Quality Assurance and Regulatory Affairs leadership experience in the medical device industry, with responsibilities for managing others.
  • Experience with FDA and EU device and facility registrations.
  • A four-year degree (an emphasis on technical/biological sciences) or demonstrated proficiency through Regulatory Affairs Certification (RAC).
  • ASQ certification preferred.
  • Needs to be well versed in FDA cGMP, ISO 13485, and related international regulatory standards.
  • Ability to successfully perform job duties in a fast pace, quick changing entrepreneurial environment