RedmondRecruiter Since 2001
the smart solution for Redmond jobs

RA Manager I

Company: Bio-Rad
Location: Redmond
Posted on: January 8, 2021

Job Description:

RA Manager IOverviewThe SO RA Manager I 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 I partners with QA 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.ResponsibilitiesAdverse 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 programSupport 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.QualificationsEducation: 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/AgeTo 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 Jobble

Keywords: Bio-Rad, Redmond , RA Manager I, Executive , Redmond, Washington

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Senior Technical Program Manager, Service Fabric
Description: The RoleThe Service Fabric team builds the foundational platform, components and tools to support a secure, resilient, distributed and scalable services ecosystem. In doing so, Service Fabric enables (more...)
Company: Outreach
Location: Seattle
Posted on: 01/18/2021

Field Case Manager (Seattle, WA)
Description: Company Overview:Mitchell, Genex and CoventryWith Mitchell, Genex and Coventry now one organization, we've dramatically expanded our ability to deliver innovative services and technologies to our customers. (more...)
Company: Genex Services
Location: Seattle
Posted on: 01/18/2021

Bond Pricing Vice President - SEA
Description: Description About this role Team Overview Data AI ensures that all portfolio information Core Enterprise Data necessary for the investment management process is complete, accurate, timely and effectively (more...)
Company: BlackRock
Location: Seattle
Posted on: 01/18/2021

Growth Marketing Manager
Description: Our client, the largest cannabis delivery provider in Southern California with exceptional growth in the last year and immediate plans to expand elsewhere in the state, is looking for a full-time direct-hire (more...)
Company: 80Twenty
Location: Seattle
Posted on: 01/18/2021

Registered Nurse - Case Management
Description: Fortus Healthcare Resources is seeking a Travel Case Management Registered Nurse for an immediate opening in SEATTLE, WA .When you join the Fortus team, you become
Company: Fortus Healthcare Resources
Location: Seattle
Posted on: 01/18/2021

Outside Sales Manager
Description: New construction Architects,
Company: Island Sash & Door
Location: Freeland
Posted on: 01/18/2021

Sr. Program Manager - PMO
Description: Want to work on one of Amazon---s most ambitious efforts Amazon's Time and Attendance team is leading the charge to build products that support our global workforce of passionate Amazonians Oh, and we (more...)
Company: amazon
Location: Seattle
Posted on: 01/18/2021

Personal Services Manager ($5000 Signing Bonus)
Description: 5,000 Signing Bonus Complimentary Parking Complimentary Meals br Era Living is seeking a full-time Personal Services Manager/Resident Care Manager LPN/RN to become the newest member of our Nursing (more...)
Company: ERA Living - The Lakeshore in Renton
Location: Seattle
Posted on: 01/18/2021

Assistant Manager
Description: The Assistant Manager assists the manager in the daily operations of a convenience store.--Fulfills the manager's duties when the manager is absent as outlined in the Store Manager job description.--They (more...)
Company: Jacksons Food Stores
Location: Maple Valley
Posted on: 01/18/2021

IT Compliance Manager
Description: Job Description - IT Compliance Manager 20576 IT Compliance Manager Job Number: 20576 Employee Status: Regular Schedule: Full Time Primary Location: San Francisco, CA Other Locations: Irvine, CA, Seattle, (more...)
Company: Moss Adams
Location: Seattle
Posted on: 01/18/2021

Log In or Create An Account

Get the latest Washington jobs by following @recnetWA on Twitter!

Redmond RSS job feeds