Principal Specialist - Regulatory Affairs

Date Posted: 10/15/2025 Hiring Organization: Rose International Position Number: 490075 Industry: Medical Equipment & Supplies Job Title: Principal Specialist - Regulatory Affairs Job Location: Cary, IL, USA, 60013 Work Model: Hybrid Work Model Details: Mon to Wed onsite, Thursday and Fri Shift: 8:00 AM to 5:00 PM Employment Type: Temporary FT/PT: Full-Time Estimated Duration (In months): 13 Min Hourly Rate ($): 93.00 Max Hourly Rate ($): 97.00 Must Have Skills/Attributes: Documentation, Regulatory, Technical Experience Desired: Regulatory issues and requirements (6 yrs); Regulatory documentation in accordance with relevant regulatory requirements for US 510(k) (6 yrs) Required Minimum Education: Bachelors Degree Preferred Education: Masters Degree C2C is not available Job Description Required Education: Bachelors (BA) degree Preferred Education: Master's degree Qualifications: Needs to have lot of experience with 510k Technical documentation, assessing gaps 9 years' experience Experience with Class IIa medical device Major Duties and Responsibilities: 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 Only those lawfully authorized to work in the designated country associated with the position will be considered. Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a clients business needs and requirements. Benefits: For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website. California Pay Equity: For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.