Compliance Engineer
4 weeks ago
Job Summary:
The Staff Product Compliance Engineer will be responsible for ensuring that our medical devices comply with all relevant regulations and standards. This includes knowledge of international regulations and standards, testing, and coordination of document packages for compliance engineering evidence.
Key Responsibilities:
- Knowledge of applicable international regulations and standards, including 21CFR, MDD, EU MDR, GSPR checklist, QSR, ISO 13485, IEC 60601, and others.
- Experienced with Test Report Forms of IEC standards and creation of regulatory and product compliance plans.
- Coordinates and prepares document packages for compliance engineering evidence to ensure alignment and compliance with local and regional registration requirements.
- Coordinates, schedules, prepares, and compiles documents for review and submission to regulatory agencies.
- Compiles all materials required in environmental compliance testing.
- Identifies and recommends procedural updates, changes in labeling, manufacturing processes, and participates in development and implementation of the same.
- Keeps abreast of regulatory and state-of-the-art changes and possesses a broad knowledge and understanding of regulations, processes, and procedures.
- Advanced PC skills with proficiency in Microsoft Office Suite, including Excel.
Qualifications:
This position requires a Bachelor's degree in Mechanical Engineering, Electrical Engineering, Science, environmental science, or equivalent focus, and a minimum of 5 years' experience in Regulatory or Product Compliance Testing or equivalent experience within a medical device company or similar organization.
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