Senior Regulatory Affairs Specialist
Type: W2 contract (NO C2C OR THIRD PARTY)
Location: Cary, Illinois (60013) -100% onsite
Length : 12-month contract - Estimated to end: 10/26/2026 - (Contract extension possibility or internal hire potential)
Pay Rate - Negotiable depending on DIRECT-related experience up to $50 - $60 an hour
Work Authorization : Must be physically located in United States and have CURRENT United States employment authorization documents WITHOUT sponsorship transfer requirements.
Job Duties:
Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
Remediation of regulatory documentation in accordance with relevant regulatory requirements for US 510(k)
Remediation of EU MDR Technical Documentation File in accordance with relevant regulatory requirements for Class IIa medical device
Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
Provides guidance to integrate regulatory considerations into global product entry and exit strategy
Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
Negotiates with regulatory authorities on complex issues throughout the product lifecycle
Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
Provides regulatory guidance on strategy for proposed product claims/labeling
Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees
Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.
(Kelly Services does not expense relocation or interview costs)
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 ® Engineering?
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About Kelly
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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.
