Xtant Medical

Regulatory Affairs/Complaint Associate

Title: Regulatory Affairs/Complaint Associate
Status: Full-Time, Non-Exempt
Location: Belgrade, MT

Summary:

Customer First. Employee Direction. Building Strategic Value. Respect for Gift of Donation.

Why Xtant Medical?

JOIN A RISING organization that unites exceptional biologics with intuitive fixation design to inspire surgical solutions that advance regenerative medicine. Our vision is to be the leader in regenerative medicine by continuously elevating the standard of care. Xtant Medical’s mission is to develop, acquire, manufacture, and commercialize innovative, quality regenerative surgical products for the treatment of degenerative, traumatic, and deformity conditions for orthopedic and neurological applications.

Principle Duties & Responsibilities

  • Process complaints per domestic and international regulations, and assist in data analysis for post market surveillance activities.
  • Assist in the management of the Corrective Action and Preventive Action processes and maintain metrics of the process.
  • Assist in the maintenance of risk management files based upon the results of post market surveillance.
  • Evaluate nonconformities (e.g. complaints, NCMRs, CAPAs) against established risk acceptance criteria.
  • Assist in data gathering for submission of Medical Device Reports (MDR’s) and EU Vigilance Reports to the FDA and European regulatory bodies in a timely manner.
  • Maintain an understanding of medical device domestic and international regulatory requirements.
  • Actively participate in internal audits. May participate in external audits as requested by management.
  • Assist in the establishment and/or updating of various regulatory and quality compliance SOPs and Work Instructions to ensure compliance to various regulations.
  • Assist in the coordination of recall activities and ensure the proper reporting and documentation of recalls per international and domestic regulations.

Knowledge/Skills Required

  • Basic knowledge of FDA and other regulatory authorities.
  • Basic knowledge of applicable regulations/guidance, include 21 CFR parts 802, 803, 806, 820, 1271 and MEDDEV 2.12/1m NEDDEV 2.12/2, AATB.
  • Basic knowledge of risk management principles and ISO 14971.
  • Interpersonal skills, organizational skills and ability to multi-task.
  • Excellent written and verbal communication skills.
  • Experience with Class II Medical Devices.
  • Medical device experience – Orthopedics preferred.
  • Project Management.
  • Strong computer skills including Windows OS, MS Word, Excel and PowerPoint.
  • Willingness to travel.

 

Education & Experience

  • Bachelor’s degree in Engineering, Science, Nursing or health-related field
  • 1 – 3 years’ experience in Quality Assurance for medical device or related industry

Benefits: Xtant Medical offers competitive wages, and comprehensive Medical, Vision, Dental, 401k, Life and AD&D, and Disability insurance packages

Xtant Medical is an equal opportunity employer.  We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors.