- Identifies, analyzes and implements country specific requirements necessary for product related submissions.
- Performs regulatory projects or acts as a member of the project steering group.
- Submits required
- Initiates and escalates necessary activities if deviations are identified.
- Ensures creation of adequate documentation for
- Performs training within the organization in country specific regulatory requirements, if applicable.
- Performs review of promotional material for regulatory compliance according to country specific requirements.
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Sr. Regulatory Affairs Specialist - Palo Alto, United States - E Staffing Inc
Description
Job DescriptionJob Description
Position Description:
*Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements
to local authorities.
Product Registration Experience:
Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files
Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.
Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO as evidenced by coursework or submissions that required use of each standardTeamwork and collaboration:
Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.
Experience with Business Tools:
Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.
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