Senior Regulatory Affairs Specialist, Labeling

Kelly® Science & Clinical is currently recruiting for a Senior Regulatory Specialist for a contract opportunity with a leading molecular diagnostics company at their Sunnyvale, CA location.

If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology realm.

Workplace : Hybrid based in Sunnyvale, CA

Position Title : Senior Regulatory Affairs Associate, New Product Development

Pay rate : $50 / hour.

Company : Kelly® Science & Clinical

Overview

This position is a 6-month contract with the Regulatory Affairs New Product Development group and located in Sunnyvale.

Responsibilities

• Familiarize yourself with Cepheid s global change control process
• Review change plans associated with product labeling
• Review implemented changes to product labeling / instructions for use
• Partner with cross-functional stakeholders to ensure accuracy of the implemented changes to labeling
• Collaborate with Technical Publications team to publish regulatory compliant labeling for Cepheid products

Qualifications

• Bachelor s degree in field with 5+ years of related work experience OR Master s degree in field with 3+ years of related work experience OR Doctoral degree in field with 0-2 years of related work experience
• In depth understanding of Regulatory Affairs concepts and should be familiar with regulations / guidelines governing development of diagnostic products and claims in labeling
• Understanding of Quality Management System regulations and standards 21 CFR Part 820 and EN ISO 13485 governing change management and Corrective and Preventative Action CAPA process
• Good organizational skills with attention to detail and accuracy Ability to prioritize, multi-task and organize work
• Maintain a focused urgency as required by specific events
• Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
• Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat

Preferred

• Labeling control and change management Corrective and Preventative Action CAPA process
• Agile documentation system

Why Join Us :

• Competitive compensation package and potential for permanent placement following the temporary period.
• Opportunity to work at the forefront of biotechnology innovation in a collaborative and dynamic environment.
• Access to ongoing career development and networking opportunities through Kelly® Science & Clinical's expansive network of industry experts and recruiters.

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey.

Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.

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.