DIRECTOR, QUALITY ASSURANCE & REGULATORY AFFAIRS

A Bay Area Medical Device Manufacturer is seeking a qualified individual for the following role:

 

DIRECTOR, Quality Assurance and Regulatory Affairs

 

DESCRIPTION:Responsible for ensuring the inspection readiness of the company, for ensuring full compliance with applicable FDA, ISO regulations and maintaining certification status. Participates in the Executive Management Review meetings.  Oversees the following functional areas: Regulatory Affairs, Regulatory Compliance, Internal Auditing Program, External Inspection (FDA, ISO), Audit related CAPAs, Document Control, Calibration Program, and QA Release Program

 Responsible for Regulatory submissions including 510(k), CLIA Wavier, Technical Files, CE Mark filing, License submissions, Declaration of Conformity and international registrations.  Prepares regulatory strategies and plans for new products and business development agreements.  Responsible for communicating product regulatory status to the organization.  Responsible for monitoring changing regulatory requirements, preparing comments on behalf of the company, apprising management of new developments and preparing processes and procedures to ensure conformance.

 Responsible for regulatory review and approval of new or revised labeling including primary label, instructions for use, user manuals, customer training materials, promotional and website related materials.  Verify labeling satisfies requirements and that claims are in line with submissions and market clearances.

 Responsible for the Internal Auditing program to assess operational compliance and to assess opportunities for program optimization. Approves annual audit schedule and any revisions.  Ensures audits are conducted per the schedule and approves audit reports.  Chairs the Audit Board and follows up to ensure timely closure of audit corrective actions.

 Serves as Quality System Expert.  Provides guidance and support on matters of FDA / ISO regulations to cross-functional departments and staff.  Responsible for developing and maintaining the Quality Manual, Quality System procedures, Quality Policy and Quality system training.

 Responsible for QA Document Control program.  Provides direction to the QA staff responsible for administering and processing document change orders. Responsible for reviewing ECOs for regulatory impact and requirements.  Responsible for management of external standards and centralized storage of quality records such as Validation reports, ECOs, DCNs, etc.

 Staff, train & provide leadership to Regulatory Compliance and Document Control depart.

 Responsible for QA Release program. Provides direction to the QA staff responsible for verifying that required quality requirements are met and authorizing the release of product for distribution

 Manages annual operating budgets to meet company objectives. Achieve quarterly operating budgets to support corporate profit goals.

 Manages scheduled and unannounced inspections performed by the FDA, ISO, and the State of California. Provides written updates to the 3rd party as documented evidence of the actions taken by the Company and petition for closure of the inspection report.

 Responsible for regulatory field action/recall process. Determines appropriate regulatory field action and various regulatory reporting and related updates. For executive management, assesses and recommends appropriate regulatory field actions to be taken by the company and handles agency communications and documentation regarding field actions/recalls.

 Participate in Quality Review Board and Quality System Management Review meetings with Executive Management. Responsible for tracking, trending and reporting on key audit and regulatory program metrics and issuing quarterly dashboard for management review.  Maintains records of Executive Quality System Management Review meetings.

 Responsible for the calibration program.  Ensures appropriate review and management of tolerance calibration reports.

 

QUALIFICATIONS: Subject Matter Expert: of ISO9001/ISO13485, CMDR and FDA Quality System Regulation; extensive working experience in medical device / diagnostic industry.

 BS degree in Business or Science, 10 years total business experience in the diagnostic industry plus 5 years progressively more responsible compliance management experience. 

 Qualified QMS Lead Auditor required; task force member of a regulatory standards committee preferred. Member of RAPs.

 Certificate of training and passed lead auditor exam; RAPs membership; ISO standards committee

 Practical minded; able to interpret the regulations and recommend workable solutions for the company.

 Demonstrated ability to present material effectively &  train others on complex topics

 Superior communication and interpersonal skills with the ability to interact with all levels of the organization. Ability to operate independently as well as part of a team. Able to influence and build consensus across functional groups.

 Superior leadership skills with the ability to build cohesive teams, cross-functional partnerships and manage in all directions.

 5+ years previous managerial experience

 Thorough knowledge of Finance as it relates to budgeting including monitoring and controlling quarterly and annual expense budgets

 Solid organization skills with ability to multi-task and balance complex/routine work

 Solid skills using MS Office, Outlook, and the Internet

 Must be able to read, write and speak English & authorized to work in the US

 Strong statistical background is a plus

 

Please e-mail resumes to: meddevicecareers@gmail.com

Equal Opportunity Employer