Director, Quality and Regulatory Affairs

2 weeks ago

Irvine, United States Bright Uro Full time

About Us:

Bright Uro is an early-stage medical technology company headquartered in Irvine, CA. We are building the next generation of diagnostic devices for Urology. Utilizing advanced hardware, software, and data science, we can unlock new data streams and offer actionable insight for clinicians.

 

The Director of Quality and Regulatory Affairs ensures continued quality systems and regulatory conformity to FDA 21 CFR 820, ISO 13485, and EU Medical Device Regulations (EUMDR). This position reports to the Chief Product Development Officer.

 

Bright Uro strives to provide its team members with an excellent benefits package including medical, dental, and vision coverage, unlimited PTO for exempt employees, Paid Company Holidays, as well as a 401(k) plan.


Position Summary:

The Director of Quality and Regulatory Affairs is a key member of the management team responsible for developing and executing quality systems, processes, specifications, and SOPs, and ensuring compliance with all relevant regulatory requirements, including federal, state, and international regulations, as well as applicable standards and guidances.

 

This role encompasses a wide range of pre and post-market Quality and Regulatory responsibilities, including supporting the development and implementation of Quality System procedures, training on Quality procedures, onsite manufacturing quality oversight, managing complaints handling and Corrective and Preventive Action process (CAPA), evaluating product and process non-conformances, and providing support to production and quality assurance teams in addressing quality-related needs.

 

In addition, this role will support regulatory activities, including serving as the regulatory resource on product development projects, specifying applicable standards and guidances for pre- and post-market compliance, and ensuring required registrations and certifications are obtained.


Essential Duties and Responsibilities:

1.  Quality Affairs

  • Develop, design, and enhance regulatory initiatives to facilitate overall regulatory compliance.
  • Participate in product development teams as the Quality Affairs functional expert and resource. Support product development teams to help meet their objectives.
  • Ensure conformity with the Quality Management System (QMS) in accordance with medical device regulations and international standards, such as FDA QSR, Good Manufacturing Practices (GMP), ISO 1385, EU MDR, etc.
  • Develop and maintain Risk Management files based ISO 14971 and applicable regulatory frameworks.
  • Manage systems for design, development, verification, validation, distribution, storage, tracking, post-market surveillance, and retrieval of information pertinent to design quality processes.
  • Ensure conformance of devices with the QMS before release and manage post-market surveillance.
  • Lead onsite resource for QMS and product audits from regulatory authorities and third party auditors. Manages planning and execution of internal audits.
  • Develop and report on quality metrics and quality initiatives, including quarterly and annual internal reporting to Executive management.
  • Establish receiving and inspection procedures; manage calibration activities for all development and production equipment.
  • Provide oversight of documentation control resources and activities.
  • Develop and train employees on quality and regulatory requirements.

 

2.  Regulatory Affairs

  • Participate on product development teams as the regulatory functional expert and resource.
  • Prepare regulatory filings and submissions based on U.S. and International requirements, in collaboration with internal teams as well as external resources.
  • Interact with regulatory bodies and provide regulatory insight to product development teas.
  • Develop and maintain Regulatory policies and procedures.
  • Manage or support pre- and post-market Regulatory Affairs processes in key Bright Uro markets, including Registration, Non-Conformities, Product Recalls, Field Actions and Medical Device Reporting.
  • Maintain and update regulatory files and binders.

Education and Work Experience Requirements:

  • Bachelor’s degree or higher in a science or engineering field.
  • Minimum of 10 years of pre-market and post-market Quality Affairs experience in a medical device and/or biopharmaceutical company. Experience working as a Quality Engineer or Manager in a regulated industry manufacturing environment is preferred. Concurrent, first-hand Regulatory Affairs experience is a plus.
  • Prior experience with medical devices, medical device software, and their quality and regulatory considerations is required.
  • Proven record of managing quality systems and ensuring compliance with FDA 21 CFR, Part 820, Quality System Regulation, and ISO 13485.
  • Extensive knowledge of U.S. FDA device regulations, including 510(k) submissions.
  • Familiarity with EU MDR, ARGMD, and Canadian Medical Device Regulations. Experience with international product registrations is a plus.
  • Strong communication skills and ability to collaborate effectively with cross-functional teams.


Additional Requirements:

  • High level of personal/professional integrity and trustworthiness with a strong work ethic and the ability to work independently and also lead and inspire a growing C&R team
  • Ability to develop and manage a high-performance team focused on accountability to meet and exceed expectations
  • Ability to technically lead, influence, create, and work within cross-functional team environments while being detailed-oriented
  • Proven technical leadership with a strong results orientation, a positive “can do” attitude, and a sense of urgency
  • Strong self-organization and documentation skills

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