What are the responsibilities and job description for the Regulatory Surveillance Expert position at Electromed, Inc.?
Company Overview
Electromed, Inc. develops innovative airway clearance devices that help people around the world breathe better, stay healthier, and lead active and fulfilling lives. We value diversity, equality, and innovation in our workplace, striving for excellence in quality and regulatory affairs.
Job Description
The Post Market Surveillance Specialist is responsible for managing customer complaints, conducting trend reporting, and reviewing medical device reports. They collaborate with stakeholders to ensure compliance with regulatory standards and maintain accurate documentation.
Required Skills and Qualifications
- High school diploma or equivalent; Associates or Bachelors preferred.
- Strong understanding of regulatory standards, including MDR, ISO 13485, and IEC 60601-1.
- Excellent communication and collaboration skills.
