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Regulatory Affairs Manager

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Regulatory Affairs Manager

  • 2020-16861
  • Redmond, Washington, United States

The Seattle Operations (SO) Regulatory Affairs Manager supervises and leads a team to coordinate and perform regulatory functions including adverse event reporting, field actions, international product registration, external standards review / implementation, and advertising / promotional material review and approval, among others. Additionally, the SO RA Manager is responsible for oversight of the internal lead auditor to plan and execute the internal audit program. The SO RA Manager I supports external audit activity by participating on audit readiness teams and interfacing with competent authorities before, during, and after external audits, as required. The SO RA Manager partners with Quality Assurance to support compliance activities related to QMS processes such as change management, risk management, post-market surveillance, management review, and production-related quality notifications. The SO RA Manager I also participates on global teams to support regulatory and quality initiatives across Bio-Rad business segments, as assigned.

Responsibilities

  • Adverse event reporting: assessing potential incidents for reportability and coordinating global reporting when necessary.
  • Field Corrective Actions: assessing potential incidents for field corrective action and executing field actions, including reporting, when necessary.
  • International Product Registration: coordination and development of technical documentation and product dossiers for submission to regional regulatory authorities. Facilitation of the review process by interacting with regional regulatory authorities through achievement of regional marketing clearance.
  • External Standards Review and Implementation: assessing emerging external requirements for applicability to Bio-Rad Seattle Operations and other business segments as assigned. Facilitating cross-functional review and implementation of applicable standards.
  • Advertising / promotional material review and approval: review and approval of marketing materials against cleared / approved product claims to ensure compliance.
  • External audits: lead and/or participate on audit readiness teams as well as interface with regulators before, during, and after external audits as required.
  • Supervise the internal lead auditor to oversee, plan, and execute the internal audit program
  • Support QMS activities including change management, risk management, post-market surveillance, and review of production quality incidents.
  • Support global RA teams and initiatives across Bio-Rad business segments as assigned.

Qualifications

Education:  Bachelor's degree, or equivalent, in Biology, Chemistry, Medical Technology, or related field.

Experience:  Minimum of 5 years experience in Regulatory Affairs with supervisory experience, or equivalent combination of education and experience relating to IVD products, including IVD products. Experience relating IVD products used in transfusion medicine, preferred. Regulatory experience should include, interaction with competent authorities to determine regulatory requirements and pathways, support regulatory submission review, and support global product registration activities.

Skills:  Proficiency in interpreting US and OUS regulatory requirements for IVD products (assays and hardware/software), including 510(k), PMA, BLA, and CE marking requirements. Ability to manage multiple complex projects with defined timelines. Excellent written and verbal communication skills required for negotiation with internal and external parties. US and/or Global RAC certification desirable.  ISO auditor certification desirable.

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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