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Lead Internal Auditor/Regulatory Affairs Specialist III

Lead Internal Auditor/Regulatory Affairs Specialist III

  • 2020-16451.2
  • Redmond, Washington, United States

The Seattle Operations (SO) Lead Auditor is a Regulatory Affairs Specialist responsible for coordinating the internal audit program and external audits at SO. The SO Lead Auditor leads and/or coordinates internal audits to assure that the SO QMS complies with applicable global regulatory standards as well as internal Bio-Rad quality objectives, policies, procedures, and standards. The SO Lead Auditor conducts regular Audit Readiness Team meetings to ensure that all external audit obligations are met in a timely manner and that the SO QMS is maintained in accordance with current requirements. The SO Lead Auditor supports internal audit activity at other Bio-Rad Core Diagnostics locations, as assigned. Future occasional travel will be required.

Responsibilities

  • Coordinate planning, approval, and execution of the annual internal SO audit schedule and program.
  • Facilitate external audit activity, including but not limited to pre-audit activity such as completion of questionnaires, provision of documents, payment of fees, and completion of contractual documents / agreements.
  • Provide direct and indirect support to audits by external parties.
  • Leads and facilitates internal teams to ensure that external audit commitments such as responses and corrective actions to findings are completed in a timely manner and that the SO QMS is maintained in compliance with relevant regulations, standards, and guidelines.
  • Prepares corporate and local standard operating procedures, training instructions, as well as inter-divisional company agreements.
  • Document management: maintains and stores current quality certificates, MOUs, contracts with auditing organizations, audit reports, Design History Files, and other records as assigned. Assists with management and oversight of the Regulatory Document File Room.

Qualifications

Education: Bachelor's degree or equivalent in Biology, Chemistry, Medical Technology, or related field.  Qualified Lead Auditor per Lead Auditor training and certification with a recognized accreditation body (ASQ certification preferred).

Experience: 5 or more years experience in regulated industry or equivalent combination of education and experience.  3 or more years working in the area of quality management systems and/or regulatory affairs

Skills:  Applicable regulations / standards training (i.e. ISO 13485, 21 CFR 820).  Working knowledge of global governing regulations, requirements, and standards such as 21 CFR Parts 803, 806, 820, 11, ISO 13485, ISO 14971, European IVD Regulation, and the Medical Device Single Audit Program / participating country regulations.

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

 

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

 

 

 

 

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