Regulatory Specialist

Job Title: Associate MDR/Vigilance Specialist – Exempt
Location: Lafayette, CO 80026
Duration: 12 Months
Pay Rate: $30/hr (W2)
Work Schedule: Full-time, 40 hours/week (Onsite at least 4 days per week in Lafayette, CO)

Job Description
We are seeking an Associate MDR/Vigilance Specialist to join its team in Lafayette, CO. The role will focus on supporting complaint handling, adverse event reporting, and compliance activities in alignment with company policies and government regulations.

Key Responsibilities:

• Support the intake, evaluation, processing, communication, and investigation of complaints and adverse events in compliance with procedures and regulations.
• Act as the primary contact for receipt, processing, and reporting of product defect complaints.
• Ensure complete and accurate documentation and reporting of Medical Device Reports (MDRs) and adverse events as required by regulatory agencies.
• Expedite product complaint resolution under company complaint-handling procedures.
• Provide technical and administrative expertise to optimize complaint processing systems.
• Maintain and monitor systems to ensure all complaint investigations are completed in accordance with company policy.
• Support projects aimed at improving programs and processes to meet evolving regulatory reporting requirements.

Required Qualifications:

• Education: Bachelor’s degree (science, healthcare, or engineering preferred).
• Experience: Minimum 1 year of relevant professional experience.
• Technical Skills:
  • Proficiency in Microsoft Office Suite (Outlook, Word, Excel).
  • Ability to read, write, and type in English proficiently.
  • Experience working in databases or OneNote preferred, but not required.
• Soft Skills:
  • Strong attention to detail.
  • Adaptability to manage multiple tasks and priorities effectively.