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Senior Regulatory Affairs Specialist, IVD

**Location** : Full remote, based out of Sunnyvale, CA

**Shift** : M-F, standard working hours

**Pay** : $47/hr-$50/hr

12 month contract role

Overview:

The Regulatory Affairs Senior Specialist role includes completing regulatory reporting assessments for anticipated manufacturing, facility, product, and packaging changes to global regulatory agencies. The position collaborate with cross-functional teams (Technical Publications, Product Transfer, Quality, R&D, Clinical Affairs) on global change control processes and ensure regulatory compliance of product labeling.

Responsibilities:

+ Familiarize with client's global change control process.

+ Review and implement changes to product labeling/instructions for use.

+ Partner with stakeholders to ensure accuracy of labeling changes.

+ Collaborate with the Technical Publications team for regulatory compliance.

Requirements:

+ Bachelor’s degree with 5+ years of related work experience OR Master’s degree with 3+ years of related work experience.

+ Understanding of Regulatory Affairs concepts and regulations/guidelines governing the development of IVD diagnostic products.

+ Knowledge of US-IVD, CE-IVDD, CE-IVDR governance for IVD diagnostic products.

+ Familiarity with Quality Management System regulations/standards (21 CFR Part 820, EN ISO 13485).

+ Experience with global registrations, regulatory dossiers, and working with core teams.

Preferred Requirements:

+ Prior knowledge of Agile PLM system, SAP ERP system, and Salesforce-based applications.

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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.