Regulatory Quality & Compliance Specialist
RemoteUnited States
Job Summary
Prepare and submit FDA submissions for new products and changes, ensuring compliance with Design Controls and GMPs. Review and approve design control documentation including Requirements Traceability Matrices and Design History Files. Participate in audit review sessions with internal or external teams and maintain engineering change requests for design and labeling updates. Draft standard operating procedures and regulatory policies while reviewing test results from functional and regression testing. Collaborate with Regulatory Affairs and Quality staff to support new products and existing product changes. Submit required candidate information including legal name, location, availability, and visa details before proceeding. Mandatory video interview required.
Required Qualifications
- Understanding of Design Controls and GMPs (Good Manufacturing Practices) as mandated by the FDA for SaMD (Software as a Medical Device)
- Prepare, write, and submit FDA submissions for new products and product changes as required in accordance with established timelines & submission dates to ensure timely approvals while in compliance with regulations
- Participate and assist in review sessions during times of audit either with internal or external audit teams
- Understanding of software product development, verification & validation, risk management, requirement analysis, and human factors
- Review and approve all design control documentation - Requirements Traceability Matrices, Verification Summary Reports, Design History Files, etc.
- Team up with Regulatory Affairs and Amgen Quality staff to provide regulatory support for new products and changes to existing products
- Serve as a subject matter expert of Regulatory and Quality Policies
- Review and write standard operating procedures (SOPs) and other RA/QA policies as necessary
- Maintain engineering change requests for design, labeling changes, etc. to ensure compliance with regulations
- Review and document test results from functional testing of new requirements, regression, and operational testing
- Proficient with Microsoft Word, Excel, and Power Point
- Please send Candidates with this information. If not sent, contractor will be rejected
- Legal name (First Name, Middle name and Last Name)
- Location (City and State)
- Relocate?
- Rate
- Availability
- Phone #
- Mobile#
- LinkedIn ID
- Email address
- Visa type
- Visa Expiration Date
- Hiring Status
- **VIDEO INTERVIEW IS MANDATORY**
Desired Qualifications
- Basic understanding of cloud technologies such as AWS (Amazon Web Services), Salesforce Cloud or GCP (Google Cloud Platform)
- Prior experience with drafting test plans/test protocols, test cases, test scripts, and test scenarios
- Prior experience with software test tools like HP ALM
- Basic knowledge of Agile methodology
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