Associate Director of Regulatory & Quality | GenomeWeb

Associate Director of Regulatory & Quality

Organization
Crescendo Bioscience - South San Francisco
Job Location
South San Francisco, California, United States, 94080,
Salary
Benefits
Job Description

The Associate Director RA/QA is responsible for the implementation and maintenance of the Quality Management System (QMS) including reporting on the performance of the QMS. He/she will represent the facility to all external Quality System Assessment agencies, such as Notified Body, FDA, CA FDB, CLIA, CAP, NY State inspectors and other regulatory/customer representatives. The Associate Director will also lead efforts in regulatory submissions supporting FDA product clearances, CE Mark certification, clinical laboratory certifications and other country product registrations. This individual will continually develop its departments to ensure effective quality assurance and regulatory compliance during organizational growth.

  • Provide leadership and management to QA/RA department staff directing efforts in all elements of the quality management system (QMS) through guidance and interpretation of regulatory requirements
  • Oversee development, implementation and maintenance of company’s QMS supporting timely development and launch of successful products while meeting regulatory requirements
  • Support completion of clinical laboratory license applications, develop content/format for regulatory submissions, such as 510(k)’s, Technical Files, CE registrations, or other international registrations and certifications.
  • Direct and provide hands-on support of activities covering regulatory affairs, quality assurance, quality control, quality system, auditing, compliant handling and document management functions. Provide hands-on support in areas of QMS where necessary.
  • Serve as Regulatory Affairs representative in review and approval of marketing/promotional materials and issuance of educational grant ensuring applicable regulations are satisfied.
  • Support Management Review Meetings through development of quality metrics reporting on ongoing performance of quality objectives and the QMS. Lead and facilitate 3rd regulatory audits.
  • Ensure design control compliance for new product development projects. Actively participate in risk management activities and ensure completeness and maintenance of Risk Management Files and Design History Files.
  • Collaborate with Purchasing and Engineering in selection, qualification and maintenance of suppliers.
  • Manage quality activities in line with the company’s expectations and department objectives working within a defined budget
  • 10+ years of experience in establishing and maintaining quality management systems within a clinical laboratory, medical device and/or in-vitro diagnostics device manufacturing environments
  • Prior experience with completing and coordinating regulatory filings for FDA and other international regulatory agencies
  • Extensive working knowledge of regulatory requirements such as CLIA, QSR, ISO13485 and EU MDD/IVDD
  • Strong collaboration, team building and development skills are essential
  • Ability to lead and coach diverse team members in achieving department effectiveness
  • Possess effective and creative analytical and problem solving skills as well as effective hands-on management skills
  • Well developed written, verbal and interpersonal skills
  • Previous experience serving as Management Representative is a plus
  • Prior experience working in emerging and growing companies desired

Education/Training:

  • The preferred candidate will have at least a bachelor’s in life sciences, or related field with a minimum of 10 years of working experience in FDA/CMS regulated environment. P rior Associate Director level or equivalent experience required
  • ASC CQA/CQE, RAPS RAC certifications desirable.

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