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Regulatory Compliance Specialist II
2 months ago
Job Summary:
HireTalent - Diversity Staffing & Recruiting Firm is seeking a highly skilled Regulatory Specialist II - Compliance to join our team. As a key member of our regulatory team, you will be responsible for implementing and maintaining the effectiveness of our quality system.
Key Responsibilities:
- Implement and maintain the effectiveness of the quality system, supporting manufacturing/operations day-to-day activities for change control.
- Provide consultation/advice to regulatory specialists for change control and product development, offering regulatory direction/interpretation on team activities.
- Interpret and apply regulatory understanding to support products and teams, ensuring compliance with relevant regulations and standards.
- Prepare U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
- Handle regulatory activities involved in documentation, labeling, field support, and ensure compliance with site and division level policies and procedures.
- Apply regulatory and technical knowledge to a wide variety of complex work assignments, maintaining and ensuring compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
Requirements:
- 2-5 years of regulatory experience and/or 2 years of relevant industrial experience, typically with a quality, product-development/support, or scientific affairs function.
- Knowledge of regulations and standards affecting IVDs and/or biologics.
- BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
