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Director RA/QA

Location : Placentia, CA (On-Site)
Job Type : Direct
Compensation : 115000.00 - 190000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 5+
Required Education : B.S. in related field or equivalent work experience

Job Description :
A medical equipment manufacturer in Orange County is seeking a Director of Regulatory Affairs & Quality Assurance. This position reports to the Chief Operating Officer 

 

RESPONSIBILITIES:


  • To ensure the company is in compliance with current industry standards as well as state and federal regulatory requirements and to ensure that management and staff are working together to produce safe and effective products. 

  • Act as the technical expert for all regulations (FDA, CE, ISO, etc.) ensuring the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.

  • Monitor external regulatory developments, identify risks, and communicate potential issues to senior management. 

  • Manage relationships within the relevant regulatory agencies to improve quality of submissions and understand the impact of any pending or proposed regulatory changes.

  • Educate/train company employees on regulatory matters to assure compliance with requirements.

  • Evaluate and develop process improvements for product issues and to improve overall quality of product and processes.

  • Manage the Supplier Program and work with contract manufacturers and suppliers to improve quality through pre‐qualification reviews, on‐going oversight and audit, implementation of engineering changes and other procedures. 

  • Assure engineering design processes and manufacturing processes are conducted in compliance with the QMS.

  • Ensure FDA, ISO, and other regulatory requirements are met.

  • Generate reports to evaluate trends and to aid management in the identification and resolution of issues and overall quality improvement effort. Review and measure compliance with quality standards and effectiveness of corrective actions.

  • Assure control and proper disposition of nonconforming products and corrective actions.

  • Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow‐up, and implementation of corrective actions.

  • Maintain and update, as necessary, the Quality Management System, develop and deliver training to ensure organization understands and embraces quality procedures and verify on‐going compliance with procedures and standards.

  • Manage complaint handling, medical device reporting, vigilance reporting, field actions, and label control. 

  • Conduct OEM technical on-boarding for sterilization and packaging validations. Assist OEMs with consulting for regulatory requirements

  • Contributes to the team effort by completing projects assigned, as needed.

  • Communicate and work well with production, purchasing, quality and senior management in accomplishing assigned goals and objectives.

  • Meet objectives of the quality management system and recommend improvements, as needed. to the Chief Operating Officer

Required Qualifications :
EDUCATION/EXPERIENCE REQUIREMENTS: 


  • English proficiency

  • B.S. in related field or equivalent work experience 

  • 5 or more years’ experience in some combination of Regulatory and Quality roles, some portion of which must include a manufacturing environment and specifically medical devices.

  • Extensive knowledge of FDA (including GMP), Medical Device Regulation (MDR) and ISO regulations strongly preferred as it relates to medical devices.

  • Adaptability and resourcefulness to roll‐up‐sleeves and multi‐task in order to thrive in small company environment.

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