Job Title: Regulatory Affairs Associate
Duration: 12 months with possible extension
Schedule: Monday to Friday, 8.00AM to 5.00PM
Job Description:
Regulatory Affairs Associate – Medical Devices
We are seeking a Regulatory Affairs Associate to support U.S. and global regulatory submissions for medical device products. This role will assist in executing global regulatory strategies, preparing and maintaining registration dossiers, and ensuring compliance with FDA, EU, and international regulatory requirements.
Key Responsibilities
Prepare and manage U.S. and global regulatory submissions, including FDA and CE technical documentation
Support execution of global regulatory strategies with oversight
Track regulatory deliverables and ensure timely, accurate submissions
Review technical and quality documentation for regulatory compliance
Collaborate with R&D and global/regional RA partners to assess regulatory impact of changes
Respond to regulatory agency and notified body inquiries under supervision
Represent Regulatory Affairs on project and product teams
Qualifications
Bachelor’s degree required (science/engineering preferred)
Direct medical device regulatory experience (NOT pharma/biotech only)
Hands‑on regulatory submissions experience
Experience interacting with FDA and/or Notified Bodies
Experience preparing Technical Files / Technical Documentation
Recent EU MDR experience, including one or more of the following:
017/745, GSPR, EU MDR remediation/compliance for Medical Device
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Key Responsibilities
Prepare and manage U.S. and global regulatory submissions, including FDA and CE technical documentation
Support execution of global regulatory strategies with oversight
Track regulatory deliverables and ensure timely, accurate submissions
Review technical and quality documentation for regulatory compliance
Collaborate with R&D and global/regional RA partners to assess regulatory impact of changes
Respond to regulatory agency and notified body inquiries under supervision
Represent Regulatory Affairs on project and product teams
Qualifications
Bachelor’s degree required (science/engineering preferred)
Direct medical device regulatory experience (NOT pharma/biotech only)
Hands‑on regulatory submissions experience
Experience interacting with FDA and/or Notified Bodies
Experience preparing Technical Files / Technical Documentation
Recent EU MDR experience, including one or more of the following:
017/745, GSPR, EU MDR remediation/compliance for Medical Device
#J-18808-Ljbffr