Job Description

Hello,

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

Title: Regulatory Quality & Compliance Specialist (Software as a Medical Device)
Location: Remote (US)
Duration: 6 + Months

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.

Nice to have:

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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About Redolent, Inc

Redolent, Inc is a leading engineering and software solution company focusing on enterprise solutions enabling its customers to realize best value on its investments.

We provide world-class solutions in Talent Management, Managed workforce, Automation Engineering, Digital and Cloud transformation, Managed Infrastructure, Google Cloud and more.

Our customized solutions of Onshore, offshore and hybrid model for Talent management and engineering solutions can fit need and budget of any client.

We are "Team Redolent", "Reaching Beyond" excellence and accelerating business transformation.

Industry

IT & Software

Company Size

11-50 employees

Headquarters

Fremont, California

Year Founded

2008

Website

redolentech.com

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