What are the responsibilities and job description for the Product Regulatory Compliance Specialist position at Electromed, Inc.?
Electromed, Inc.
We are a leading developer and manufacturer of innovative airway clearance devices that help people breathe better and stay healthier. Our mission is to make life's important moments possible for individuals around the world.
Job Description:
The Post Market Surveillance Specialist plays a critical role in ensuring compliance with regulatory standards by managing customer complaints through thorough evaluation and investigation. 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. The successful candidate will be part of a dynamic team that values innovation and quality in a rapidly changing environment.
Key Responsibilities:
- Manage customer complaints through detailed evaluation and investigation, ensuring compliance with regulatory standards.
- Collaborate with internal stakeholders and project teams to develop and execute regulatory strategies.
- Support quality and regulatory system improvements, maintain documentation, and participate in audits.
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.
