NEW JOB OPENING
SENIOR REGULATORY AFFAIRS SPECIALIST
IN Cary, IL, USA!

 

Date Posted: 06/17/2026
Hiring Organization: Rose International
Position Number: 502984
Industry: Medical Equipment & Supplies
Job Title: Senior Regulatory Affairs Specialist
Job Location: Cary, IL, USA, 60013
Work Model: Onsite
Shift: 8:00 am - 5:00 pm, M-F
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 13
Min Hourly Rate($): 55.00
Max Hourly Rate($): 60.00
Must Have Skills/Attributes: Medical device, Regulatory, Regulatory Affairs
Experience Desired: Regulatory Affairs experience within the medical device industry (6 yrs); Direct experience with U.S. 510(k) submissions and EU MDR Class IIa devices (5 yrs); Strong knowledge of U.S. and international medical device regulations (5 yrs); Experience developing regulatory strategies and managing regulatory submissions (5 yrs)
Required Minimum Education: Bachelor’s Degree
Preferred Education: Master’s Degree
Preferred Certifications/Licenses: Regulatory Affairs Certification

**C2C is not available**

 

Job Description
Required Education:

• Bachelor’s degree in engineering, Science, Regulatory Affairs, or a related field required



Preferred Education:

• Master’s degree in Regulatory Science



Preferred certifications:

• Regulatory Affairs Certification



Required Experience & Skills:

• Minimum 6 years of Regulatory Affairs experience within the medical device industry

• Direct experience with U.S. 510(k) submissions and EU MDR Class IIa devices

• Strong knowledge of U.S. and international medical device regulations

• Experience developing regulatory strategies and managing regulatory submissions

• Familiarity with Technical Documentation Files, compliance, and post-market regulatory activities

• Strong analytical, problem-solving, and communication skills

• Ability to work independently and collaborate with cross-functional teams



Job Duties:

• Develop and execute regulatory strategies throughout the product lifecycle

• Prepare, review, and submit regulatory filings, including U.S. 510(k) and EU MDR documentation

• Provide regulatory guidance to product development, quality, clinical, and manufacturing teams

• Assess regulatory requirements, product classifications, and approval pathways

• Monitor regulatory changes and ensure ongoing product compliance

• Support interactions with regulatory authorities and respond to agency requests

• Review product claims, labeling, and technical documentation for compliance

• Assist with regulatory inspections, audits, SOP development, and training activities

• Support remediation of regulatory documentation and Technical Documentation Files

• Collaborate with cross-functional teams to ensure regulatory compliance and successful product approvals
  • **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.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

 

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About Rose

  • Founded in 1993
  • Office Locations Across the U.S.
  • 150+ Clients: Corporations and Government Agencies
  • Employee Oriented Company
  • Challenging Assignments Across the U.S.
  • Continuous Professional Development

Rose International was not only attentive and responsive, but they were very professional and helpful whenever I called or needed any assistance.

Diane, Consultant

Thanks for the opportunity. If in the future I ever need a job, I would like to work for Rose International.

David, Consultant

Your team at Rose International is always very helpful and responsive.

Barbara, Consultant

Rose International maintained good communication during assignments and are very informative through email and phone calls.

Sade, Consultant

As a contractor, I have to say that Rose International was by far the best agency I have worked for.

Q'testdalir, Consultant

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