Senior Regulatory Affairs Specialist (No C2C)

Job description

**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.

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Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

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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.

Required Skill Profession

Other General