Staff Product Compliance Specialist
4 weeks ago
Job Summary
We are seeking a highly skilled Product Compliance Professional to join our team at Stryker Global Technology Center Pvt Ltd. This role will be responsible for ensuring compliance with international regulations and standards for our medical devices.
Key Responsibilities
- Knowledge of applicable international regulations and standards, including 21CFR, MDD & EU MDR, GSPR checklist, QSR, ISO 13485, IEC 60601, and others.
- Experience with Test Report Forms of IEC standards and creation of regulatory and product compliance plans.
- Coordination and preparation of document packages for compliance engineering evidence to ensure alignment and compliance with local and regional registration requirements.
- Compilation of documents for review and submission to regulatory agencies.
- Identification of procedural updates, changes in labeling, manufacturing processes, and participation in development and implementation of the same.
- 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. Professional knowledge gained through substantial applicable work experience is also required. A minimum of 5 or more years' experience in Regulatory or Product Compliance Testing is preferred.
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