Regulatory Specialist
3 weeks ago
Triple Crown is a leading provider of hardware, embedded, software, and mechanical engineering talent. Businesses and technology teams, from Fortune 500 enterprises to emerging startups, rely on our ability to rapidly place the developers, architects, coders, and designers who engineer digital transformation and growth.
CONTRACT position: 6 to 9 Month Duration
Location: Union City, CA
Engineer will be ensuring the quality of medical device equipment for a medical technology company.
Job Description:
- Understand, follow and support internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).
- Under the direction of the Manager, Regulatory Affairs compile, prepare, review, and submit regulatory submission documents for the company in the U.S. as well as internationally including but not limited to Device Master files, technical files, annual reports, amendments, supplements, etc.
- Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
- Maintain regulatory database of regulatory information and submissions.
- Review, recommend and present regulatory policies, methods, SOPs, protocols, reports for regulatory compliance and report on findings to assure adherence to FDA and global requirements.
- Assist regulatory management and teams in the implementation and delivery of regulatory documentation.
- Maintain and develop timelines for regulatory submissions, and correspondence for company sponsored projects.
- Under the management direction, maintain the Device Manufacturing licenses as required and mandated by the state and/or other regulatory agencies.
- Assist regulatory management and subject matter experts in the coordination of briefing documents and responses to requests or questions from government authorities or other entities.
Skills:
- RA Specialist
- Medical Devices
- Product registration, submission or post market experience
Benefits:
- Paid weekly
- Health, dental and vision insurance
- 401K
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