Regulatory Affairs Specialist - STL MO - Kelly Services
Saint Louis, MO 63110
About the Job
Regulatory Affairs Specialist – STL MO
Kelly Science and Clinical is currently recruiting for a qualified, full-time, temporary to potential permanent Regulatory Affairs Specialist for one of our clients. The position is in St. Louis, MO, and the need to fill this position is immediate.
Summary of the Position:
The Regulatory Affairs Specialist reports to the Director of QA and performs surveillance and advocacy activities for in vitro diagnostics (IVDs) according to assigned tasks and will assist in helping the company maintain compliance to 13485:2016 and IVDR requirements, which requires regulatory assessment of new product design, CAPA investigations, and document filing.
Responsibilities:
Qualifications/Education/Skills:
Hours: Mon - Fri, 8A – 5P – this role will start fully onsite and transition to possibly hybrid once business acclimation occurs.
For immediate consideration, please contact me directly at Tierra.Barbour@kellyscientific.com or at 804-991-0745.
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.
Kelly Science and Clinical is currently recruiting for a qualified, full-time, temporary to potential permanent Regulatory Affairs Specialist for one of our clients. The position is in St. Louis, MO, and the need to fill this position is immediate.
Summary of the Position:
The Regulatory Affairs Specialist reports to the Director of QA and performs surveillance and advocacy activities for in vitro diagnostics (IVDs) according to assigned tasks and will assist in helping the company maintain compliance to 13485:2016 and IVDR requirements, which requires regulatory assessment of new product design, CAPA investigations, and document filing.
Responsibilities:
- Performing surveillance and advocacy activities for medical devices according to assigned tasks
- Providing support and counsel in tasks pertaining to regulatory registrations, listings, and compliance, with specific emphasis on adhering to the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR); maintaining compliance with requirements of FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other applicable International Medical Device Regulations
- Managing regulatory review for CAPA investigations, adverse events, validations, and general projects (removed printed materials & added adverse events)
- Supporting preparation of and participate in audits by regulatory authorities and customers
- Supporting new product development projects through regulatory assessments
- Addressing regulatory queries and requests from both internal stakeholders and external customers
Qualifications/Education/Skills:
- Bachelor's degree (or higher) in a life science discipline (biology, chemistry, etc.) and/or equivalent experience
- Must have international regulatory experience. This can be in a multitude of areas such as IVD product submissions (preferred), product labelling, or product complaints
- A minimum of 5 years' experience in Regulatory Affairs or related role
- Previous experience in a life science organization
- Strong communications skills
- Proficiency in Excel, Word and PowerPoint
- Ability to proactively identify complex problems and needs and develop solutions/recommendations to solve problems
- Strong analytical, technical and organizational skills
- Ability to sit and stand for up to periods of four (4) hours
- Ability to lift up to thirty (30) pounds in an office environment
Hours: Mon - Fri, 8A – 5P – this role will start fully onsite and transition to possibly hybrid once business acclimation occurs.
For immediate consideration, please contact me directly at Tierra.Barbour@kellyscientific.com or at 804-991-0745.
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.
Source : Kelly Services