Risk Management SME

Mount Talent Consulting

10 - 14 years

13 - 20 Lacs

Pune

Posted:1 month ago| Platform:

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Skills Required

Risk Management regulatory Quality systems Trace matrix ISO RMF EU USFDA RMM Regulatory Affairs Subject Matter Expertise BRD MDSAP Risk Analysis MDR ISE EUMDR

Work Mode

Work from Office

Job Type

Full Time

Job Description

Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline;
10+ years of professional experience in medical device in Risk management , regulatory Quality systems EU MDR, US FDA and closely working R&D, Regulatory Affairs & design quality organizations
Strong proven experience in simplifying/reviewing RMM,BRD, RMF, Trace matrix, DHFs, Design requirements, IFUs, Risk management , V&V activities etc.
Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC , ISO.
Experience with systems for quality management, product development, and follow-up of procedures
Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.)
Ensures that appropriate Quality Plans are made that include all stages product life cycle ,supports Quality Plan
Validate key design inputs like : Usability, Reliability, Performance, Supportability, Manufacturability, Safety, Security, Privacy, Serviceability, Sustainability etc.
Provides effective oversight of the execution of the Quality Plan, Risk Management activities, and all design related activities during the product/system life cycle
Performs independent technical assessment on product quality performance and post-market product quality analysis
Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
Act as a single point of contact (person assigned to project team) responsible t ensure that hardware design meets quality and compliance standards for every milestone etc.)

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