What are the responsibilities and job description for the Post-Market Monitoring Specialist position at Electromed, Inc.?
Electromed, Inc.
At Electromed, we value innovation and quality in a rapidly changing environment. We are committed to making life's important moments possible for individuals around the world.
Job Description:
The Post Market Surveillance Specialist is responsible for managing customer complaints through thorough evaluation and investigation, ensuring compliance with regulatory standards. This involves collaborating with internal stakeholders and project teams to develop and execute regulatory strategies, contributing to product safety, efficacy, and regulatory approval processes.
Responsibilities include supporting quality and regulatory system improvements, maintaining documentation, and participating in audits to enhance organizational compliance and efficiency.
Key Outcomes:
- Intake, evaluate, and process customer complaints, ensuring each investigation is comprehensive, accurate, and detailed.
- Participate in root cause investigations and product analysis to address underlying issues of customer complaints.
- Conduct trend reporting to identify significant findings and escalate these to Quality Engineering (QE) or relevant investigating stakeholders as necessary.
Requirements:
- High school diploma or equivalent; Associates or Bachelors preferred.
- Comprehensive understanding of key regulatory standards and directives, including European Union Medical Device Regulation (MDR), ISO 13485, IEC 60601-1.
- Experience supporting regulatory strategies, documentation preparation, and compliance activities.
- Exposure to FDA inspections, ISO 13485 audits, and regulatory communications.
