Senior Regulator Affairs Specialist Job Listing at Kelly Services in Sunnyvale, CA (Job ID US3523377_BH9688259)

Description

Senior Regulatory Affairs Specialist I
Overview:
The Senior Regulatory Affairs Specialist I, NPD is responsible for evaluating and ensuring labeling accuracy for client's in vitro diagnostic products. This role offers a unique opportunity to collaborate with cross-functional teams, including Technical Publications, Product Transfer, Quality, R&D, and Clinical Affairs, as part of client's global change control process. The position ensures regulatory compliance of product labeling and offers exposure to diverse array of in vitro diagnostic products, innovative technologies, and tools that implement continuous improvements and introduce new products to market.

Location: Sunnyvale, CA (Hybrid)
Shift: M-F, standard working hours
Contract Duration: 6 months
Pay: $50/hr

Responsibilities

• Familiarization: Understand global change control process.
• Review and Implementation: Review change plans and implemented changes to product labeling/instructions for use.
• Cross-functional Collaboration: Partner with stakeholders to ensure accuracy in labeling changes.
• Regulatory Compliance: Work with the Technical Publications team to publish regulatory-compliant labeling for products.

Requirements:

• Bachelor's degree with 5+ years of related work experience OR Master's degree with 3+ years of related work experience OR Doctoral degree with 0-2 years of related work experience.

• In-depth understanding of regulatory affairs concepts and familiarity with regulations/guidelines for diagnostic product development and labeling claims.
• Understanding of QMS regulations and standards (21 CFR Part 820 and EN ISO 13485) governing change management and CAPA.
• Skilled with Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.

Preferred Requirements:

• Experience in labeling control and change management.
• Familiarity with the Corrective and Preventative Action (CAPA) process.
• Experience with Agile documentation systems.

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 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. 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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