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 : Bachelor’s Degree
Preferred Education : Master’s Degree
Please read the following job description thoroughly to ensure you are the right fit for this role before applying.
Job Description
Required Education :
Bachelors (BA) degreePreferred Education :
Master's degreeQualifications :
Needs to have lot of experience with 510kTechnical documentation, assessing gaps9+ years' experienceExperience with Class IIa medical deviceMajor Duties and Responsibilities :
Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategyRemediation 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 deviceDevelops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategiesProvides guidance to integrate regulatory considerations into global product entry and exit strategyAssesses all requirements and potential obstacles for market access and distribution (federal, provincial / territorial / state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstaclesCritically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulationsNegotiates with regulatory authorities on complex issues throughout the product lifecycleEstablishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distributionIdentifies the need for and manages the development and execution of new regulatory procedures and standard operating proceduresDevelops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide complianceEvaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutionsEvaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissionsReviews and assesses proposals to regulatory authorities on regulatory paths and clinical plansProvides regulatory guidance on strategy for proposed product claims / labelingEnsures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claimsPrepares cross-functional teams for interactions with regulatory authorities including panel / advisory committeesOnly 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 client’s 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 :
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