Canutillo, TX

Director Quality Assurance/Regulatory Affairs

Canutillo, Texas Jobs

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$49,455 - $60,445

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Director Quality Assurance/Regulatory Affairs

Position Overview:

The Director QA/RA will be responsible for leading all quality and regulatory activity in support of company growth objectives. Reporting to the CEO, the Director QA/RA will be a key partner in leading QA/RA capabilities and qualifications to enable several important strategic initiatives.

Responsible for managing quality systems development and maintenance and coordinating regulatory activities. This will require a broad, working knowledge of all key aspects of both disciplines. The immediate need and focus will be on the company’s Quality Systems, with the Regulatory responsibilities increasing over time. Strong leadership and team skills will be important to guiding and aligning the internal team and external consultants.

A key part of the senior leadership team the Director QA/RA will be a strong advocate for their function and will partner with other functions, particularly operations, to drive the implementation of their strategy. The Director QA/RA will be analytical, results and process driven by nature, possess strong interpersonal skills, and have a desire and passion for quality and regulatory compliance.


  • Define regulatory requirements necessary for class 1 medical device products, however, understand the needs of class 2 and 3 medical device customers, as well as cGMP to support new product and product modifications as required
  • Lead regulatory activities for product field corrective actions, post market activities to maintain compliance and ensure that product approvals are properly maintained and managed
  • Oversee audit and inspection of processes and products, ensuring that the various functional areas of the company are in compliance with regulations
  • Provide Quality oversight of manufacturing operations
  • Conduct internal and external cGMP audits and write audit and summary reports, participate in the full audit response and corrective action (CA) process, and verify implementation of CAs
  • Coordinate with QA, Engineering, Sourcing and Manufacturing to ensure all necessary regulatory activities related to their areas of operations are well implemented
  • Review manufacturing documentation and specifications for regulatory compliance
  • Serve as customer team liaison for customer audits/questions related to specification requirements
  • Work directly with customers, as required, in support of the customer teams, interfacing on change notification activities, clarification of status and other such communication
  • Monitor and report on key quality and performance indicators as related to regulatory system conformance
  • Disseminate regulations and guidelines with appropriate interpretation
  • Keep updated on latest and future regulatory requirements, incorporating changes and additions into review and audit practices
  • Author, review and/or approve internal operating procedures related to regulatory affairs
  • Conduct regulatory activities and interact with regulatory agencies to ensure compliance
  • Represent Quality and Regulatory functions during customer and agency audits
  • Perform advanced QSR training and related GMPs

Additional Required Skills/Abilities:

  • Extensive experience in preparing and leading engagements directly with regulatory agencies. Ability to coach others to do the same.
  • Ability to work independently in a dynamic, complex, operations environment
  • Strong organizational and communication skills, both written and presentation.
  • Working knowledge of multiple business functions, including operations, quality, logistics, finance, sales, customer service, engineering, IT, and human resources
  • Identifies and drives strategic improvements and leads cross-functional teams
  • Ability to work independently and cross-functionally. Ability to effectively lead and manage change
  • Excellent communication and organizational skills
  • Able to work with a diverse group of individuals and styles
  • Experience operating in global environment
  • Respect and adherence to timelines with a willingness to do what is necessary to get the job done
  • Self-motivated, willing to learn
  • Travel typically 10%, but flexing higher when needed


  • Bachelors' Degree in a technical discipline, Master's Degree is preferred.
  • 7+ years of Quality and/or Regulatory Affairs experience in the medical device field with 4+ years in a management role
  • Strong knowledge of FDA / GMP regulations.
  • Understanding of European quality and regulatory approaches a bonus
  • Specific QA/RA training and qualifications preferred


  • A competitive compensation package, including base salary, short-term incentive, equity and benefits will be provided.

Job ID: 7638116316499639618

This job is located in

Canutillo, Texas, 79835

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