296 Compliance Specialist

Kardium has a unique opportunity for an experienced medical device reporting (MDR) Compliance Specialist. As a member of the QA team, the MDR Compliance Specialist will be responsible for the intake, documentation, medical device reporting, and investigation of complaints for Kardium products in accordance with applicable internal procedures, regulations and regulatory guidance worldwide.

Responsibilities

Position responsibilities include the following:

  • Coordinate the development, implementation, and improvement of internal QMS processes and methods to maintain MDR/vigilance compliance and support post-market surveillance.
  • Assemble and coordinate a cross-functional Review Board to collaboratively review and investigate customer complaints and adverse events reported to Kardium, in order to meet regulatory obligations.
  • Assess complaint files for completeness and correctness, and communicate with Kardium field personnel, health care providers, and patients to gather additional information as required.
  • Ensure that complaints, adverse events, and product malfunctions are investigated in a timely manner, by coordinating with internal resources, Kardium field personnel, and/or customers as appropriate to determine root causes, contributing factors, and device relationship within the time frames required by applicable regulations and regulatory guidance.
  • Provide subject-matter expertise to support the Review Board’s decision-making process.
  • Ensure that the results of investigations and determinations made by the Review Board, including reportability decisions, are accurately documented, and that meeting minutes are recorded and action items are assigned/completed, as required. Ensure all required records are complete and accurate, and have been reviewed/approved by appropriate stakeholders, including incident reports, recall reports, and recall status reports.
  • In collaboration with the Regulatory Affairs, Compliance and Quality Engineering teams, prepare, submit and manage applicable reports and documentation to regulatory agencies, in accordance with regulatory requirements, and prepare responses to queries from regulatory agencies.
  • Escalate issues requiring additional input and oversight by Kardium executive management representatives, as needed.
  • Assist with the planning, implementation and effectiveness verification of corrective and preventive actions.
  • Provide necessary support and training to employees, to ensure compliance with all applicable standards and regulations.
  • Coordinate data collection for trending purposes, and develop, prepare, and analyze periodic trend reports for complaints and adverse events as required.
  • Support internal and external audits and inspections, as required.

Education & Experience

  • Bachelor’s degree in health care, health sciences or biomedical engineering or equivalent combination of education and highly relevant experience.
  • At least 2 years’ hands-on experience with medical device reporting or complaint handling.
  • Strong, in-depth working knowledge of medical device reporting requirements in ISO 13485, U.S. CFR, European MDD and MDR, and relevant regulatory guidance documents.
  • Experience with electronic document and electronic record management systems.

Skills

  • Strong analytical skills and critical thinking.
  • Effective written and verbal communication and technical documentation skills.
  • Excellent computer skills (MS Office, Excel).
  • Able to operate independently with minimal direction.
  • Organized and detail-oriented.
  • Excellent interpersonal skills including the ability to resolve conflict with poise, diplomacy and tact.
  • Ability to work effectively as part of a team and collaborate with staff at all levels.
  • Flexible and adaptable to take on additional responsibilities as appropriate.

How to Apply

If this position appeals to, apply today by sending your résumé and cover letter to jobs@kardium.com, with the job title “296 Compliance Specialist” in the subject line.

To apply for this job email your details to jobs@kardium.com