Vigilance and Compliance Associate

2 weeks ago


GondrecourtleChâteau, Grand Est, United States Redbock - an NES Fircroft company Full time

**CANDIDATES CURRENTLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLY**

Position: Regulatory Compliance Associate (Contract Role)

Work Arrangement: Hybrid

Key Qualifications:

  1. Experience in Medical Device Reporting
  2. Background in healthcare
  3. Familiarity with the medical device sector

Primary Responsibilities:

  1. Assess incoming complaints from various sources
  2. Conduct follow-up inquiries for additional information
  3. Prepare and submit regulatory documentation

Role Overview:

As a Regulatory Compliance Associate, you will play a vital role in documenting and assessing product feedback and analysis results for surgical devices. Your responsibilities will include determining the status of complaints and regulatory reporting in alignment with both US and international regulatory standards. You will compile reports for regulatory agencies, ensuring compliance with all necessary guidelines.

Key Duties:

  • Implement policies and procedures to adhere to FDA and international regulations.
  • Oversee the surveillance program for medical devices, including the intake and evaluation of adverse event reports.
  • Analyze incoming data to ascertain eligibility for Medical Device Reporting and Vigilance reporting.
  • Guarantee the accurate and timely submission of Medical Device Reports (MDRs) and Vigilance Reports (VR).
  • Collaborate with internal and external stakeholders to efficiently gather complaint information.
  • Stay informed about new products and regulatory requirements.
  • Act as a liaison to develop processes that meet regulatory reporting standards.

Essential Qualifications:

  • Bachelor's degree
  • Proficient in computer applications (e.g., Microsoft Office, SAP, Siebel, Oracle Clinical)
  • 0-2 years of experience in healthcare or the medical device/pharmaceutical industry, focusing on safety or clinical data evaluation

Preferred Qualifications:

  • Degree in Health Care, Sciences, or Biomedical Engineering
  • Experience in the medical device industry
  • Excellent verbal and written communication skills
  • Understanding of basic anatomy and physiology
  • Strong attention to detail
  • Advanced computer skills


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