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Director Quality Assurance/Regulatory Affairs

Company: hireneXus
Location: El Paso
Posted on: November 17, 2021

Job Description:

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. Responsibilities:

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

Keywords: hireneXus, El Paso , Director Quality Assurance/Regulatory Affairs, Executive , El Paso, Texas

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