Medical Device Regulatory Affairs Project Manager
1 week ago
Details:
- Pay for this position is 46.00 to 50.00 hourly depending on experience.
- This position is a one year contract with the possibility of extension or conversion to permanent.
- Location: Santa Clara, CA – 100% onsite.
Education and Experience Required:
- Bachelor’s Degree in life sciences or engineering, or other technical discipline
- Technical or Medical Writing experience
- Class I and II medical device experience
- Must be familiar with relevant US/international regulatory requirements for medical devices including Quality Systems standards and clinical investigations
- Proficient with MS Office Suite (Word, Excel, PowerPoint, Outlook)
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Summary:
- We are recruiting for a Regulatory Affairs Project Manager to join our team at the Santa Clara, CA location. In this role, you be responsible for coordinating, planning, preparation, assembly, and review of regulatory strategies and/or submissions to the FDA and other worldwide regulatory agencies as well as daily regulatory operations
- Perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry of instrument hardware and software.
- Conduct reviews of product and manufacturing changes of instrument hardware and software for compliance with applicable regulations.
- Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise.
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