Head of Regulatory Affairs and Quality
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POST DATE 9/16/2016
END DATE 11/29/2016
JOB DESCRIPTIONJob Description
Bio-Rad Laboratories DBC-C (Digital Biology Center Cambridge), provides the only fully-integrated DNA sequencing platform designed to meet the work-flow requirements of both research and clinical laboratories; offering both a fully integrated sequencing platform and consumables to power the system. We are looking for a Head of Regulatory Affairs and Quality Systems to join our senior management team.
The Head of Regulatory Affairs and Quality Systems will be a key member in the Division's senior management team, responsible for developing and maintaining an ISO 13485 and FDA QSR compliant quality management system. The Head of Regulatory and Quality leads all regulatory strategies and manages the regulatory process to ensure approval from various Health Agencies.
This individual will work with other department heads to define internal strategies for continuing the establishment and implementation of quality systems. This person will be expected to provide hands-on leadership across a range of in vitro diagnostic devices, as well as building a regulatory affairs and quality team. This will require project management skills, planning and on time completion of tasks, with strong hands-on technical capability.
This position will be responsible for developing, submitting and obtaining FDA clearance/approval, IVD-CE mark and Rest of the World (RoW) approvals for DNA Sequencing and Analysis IVD devices.
* Management Representative in an FDA QSR and ISO 13485 regulated environment
* Developed, submitted and successfully obtained FDA 510(k) clearances
* Developed, submitted and successfully obtained IVD-CE mark
* Expert in ISO 13485 and FDA QSR
* Expert in ISO 14971
* Knowledgeable of IEC 62304 Medical Device Software SDLC
* Extensive experience with all aspects of the Medical Device Directive (MDD) or Vitro Diagnostic Directive (IVDD)
* Resolution of FDA Recalls a big plus
* Bachelor s degree or higher in a related engineering and/or technical discipline. Master's Degree preferred
* 8+ years experience or equivalent combination of education and experience working in an FDA QSR and ISO 13485 regulated environment for a product manufacturer
* Advanced knowledge of and application of principles and theories of quality engineering
* Experience managing a staff of Quality Assurance and Regulatory Affairs professionals
* Strong communication, technical, and computer skills
* Coordination, tact and team work
* Direct experience working with IVDs and DNA Sequence Analyzers a big plus
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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.