[Hiring] Regulatory Quality & Compliance Specialist @Redolent

Role Description

One of our direct clients is urgently looking for a Regulatory Quality & Compliance Specialist (Software as a Medical Device).

• 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.
• Perform other related duties and projects as business needs require at the direction of management.
• Proficient with Microsoft Word, Excel, and Power Point.

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.

Requirements

• 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:

Benefits

• **VIDEO INTERVIEW IS MANDATORY**