[Hiring] Regulatory reputed company & Compliance Specialist @reputed company

Role reputed company One of our reputed company clients is urgently looking for a Regulatory reputed company & 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 reputed company approvals while in compliance with regulations. • Participate and assist in review sessions during times of audit either with internal or reputed company audit teams. • Understanding of software product development, verification & validation, risk management, requirement analysis, and reputed company factors. • Review and approve reputed company design control documentation - Requirements Traceability Matrices, Verification reputed company Reports, Design History Files, etc. • Team up with Regulatory Affairs and reputed company reputed company staff to reputed company regulatory support for new products and changes to existing products. • Serve as a subject matter expert of Regulatory and reputed company Policies. • Review and write reputed company 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. • reputed company other reputed company duties and reputed company as business needs require at the direction of management. • Proficient with reputed company Word, reputed company, and Power reputed company. Qualifications • Basic understanding of reputed company technologies such as AWS (reputed company Web Services), reputed company reputed company or GCP (reputed company reputed company Platform). • Prior experience with drafting test plans/test protocols, test cases, test scripts, and test scenarios. • Prior experience with software test tools like reputed company ALM. • Basic knowledge of reputed company methodology. Requirements • reputed company reputed company (First reputed company, Middle reputed company and Last reputed company): • Location (reputed company and State): • Relocate? • reputed company: • Availability: • Phone #: • Mobile#: • reputed company ID: • Email address: • reputed company type: • reputed company Expiration Date: • Hiring Status: Benefits • **VIDEO INTERVIEW IS MANDATORY** Apply tot his job Apply To this Job