Regulatory Affairs Manager, Diagnostics/IVD Job Listing at Kelly Services in Seattle, WA (Job ID US3587298_BH9910185)

Description

Kelly® Science & Clinical is seeking a Sr. Regulatory Affairs Manager for a contract-to-hire position at a cutting-edge client in Seattle, WA . If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Must be able to work Pacific Coast hours.

The Sr Regulatory Affairs Manager is responsible for supporting the development and operations team's compliance with FDA, CLIA, CAP, IVDR, and other global regulatory requirements. This position will be responsible for working cross-functionally to support key regulatory submissions as well as interfacing with regulatory authorities and key business partners.

Key Responsibilities and Essential Functions

· (Oversees or Manages) regulatory filings for new product introductions, and expanded indications, including providing guidance for requirements and authorizing/reviewing regulatory filing documentation

· Oversees/Manages submissions in multiple ex-US jurisdictions, including the EU, APAC, Australia, and assume regulatory responsibility for compliance with IVDR.

· Develops and executes change notification strategies for changes to registered products, both in the U.S. and globally

· Contributes to agency communications in the event of notifiable nonconformances or adverse events

· Owns and manages applicable regulatory processes and documents

· Works with quality system process owners to identify and interpret applicable regulations and to mitigate any gaps

· Reviews incoming project contracts and provide guidance for regulatory requirements for projects

·Informs the cross functional team of any new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product and provide the appropriate data to the Project Lead to prepare Post Launch Monitoring Annual Report

Required

· Bachelors + 12 years of related experience, or Masters + 8 years of related experience, or PhD + 5 years of related experience

· 6-8 years of regulatory experience in a medical device and/or diagnostics company involved with development, manufacturing, testing and distributing products or similar experience

Preferred

· Experience managing regulatory filings with the FDA, EU, and other ex-US regulatory bodies is highly preferred.

· Experience with U.S. and international IVD regulations

· Broad knowledge of post market surveillance regulations, practices, and procedures

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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