Date Posted: 11/05/2026
Hiring Organization: Rose International
Position Number: 510373
Industry: Healthcare
Job Title: EU MDR Regulatory Affairs Consultant
Job Location: Remote, USA
Work Model: Remote
Shift: 8 to 5, Monday to Friday
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 10
Min Hourly Rate($): 70.00
Max Hourly Rate($): 72.00
Must Have Skills/Attributes: Medical device, Regulatory
Experience Desired:
Strong, hands-on EU Medical Device Regulation (EU MDR) expertise (5 yrs),
EU MDR technical documentation experience (5 yrs),
EU MDR change assessments experience (5 yrs)
Required Minimum Education: Bachelor’s Degree
Job Description
Required Education:
-Bachelor's degree or country equivalent in a scientific, engineering, regulatory, or related discipline
Required Experience:
-Minimum 5 years of Regulatory Affairs or related medical device experience
-Experience with complex medical devices and medical device software
Required Skills:
-Primary Requirement: Strong, hands-on EU Medical Device Regulation (EU MDR) regulatory expertise
-Demonstrated experience applying EU MDR requirements throughout the medical device product lifecycle
-Experience with EU MDR technical documentation, change assessments, and Notified Body interactions
-Regulatory experience with Connected Monitoring and/or Respiratory Health medical products, including software
-Ability to interpret requirements, identify compliance risks, and prepare clear regulatory assessments and documentation
-Ability to work independently on assigned activities while collaborating effectively within cross-functional core teams
-Strong written and verbal communication skills
Serve as the Regulatory Affairs core team representative for EU MDR compliance and lifecycle activities supporting Baxter Connected Monitoring and Respiratory Health medical products, including associated software. Execute assigned regulatory activities, maintain documentation, assess product changes, and support cross-functional project teams.
Essential Duties and Responsibilities:
-Serve as the RA core team representative for assigned Connected Monitoring and Respiratory Health products, including software.
-Execute EU MDR regulatory activities for product changes, technical documentation, submissions, and lifecycle maintenance.
-Assess product changes for EU MDR impact, identify compliance gaps and risks, and escalate issues as appropriate.
-Prepare, review, and maintain EU MDR technical documentation and regulatory deliverables.
-Develop clear regulatory assessments and justifications with support from senior RA staff as needed.
-Support interactions and responses to EU Notified Bodies and regulatory authorities, as required.
-Work with Engineering, Quality, Clinical, Medical, Marketing, and other functions to incorporate regulatory requirements into project deliverables.
-Manage assigned priorities and timelines and communicate regulatory risks and issues proactively
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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