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Principal Specialist - Regulatory Affairs
Principal Specialist - Regulatory AffairsRose International • Cary, Illinois, US
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Principal Specialist - Regulatory Affairs

Principal Specialist - Regulatory Affairs

Rose International • Cary, Illinois, US
4 days ago
Job type
  • Full-time
  • Temporary
Job description

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.

  • 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 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 :

    For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

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    Regulatory Specialist • Cary, Illinois, US

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