Please share your resume at. jobs@starkassociatesllc.com. Job title: Sr. Regulatory Affairs Specialist. Location: Indianapolis, IN. Contract: W2. Summary Description. Independently provide EU regulatory requirements and guidance to EU MDR project teams. Lead the preparation of the EU MDR technical documentation for Class III, IIa, IIb, or Class I sterile or reusable medical devices to support timelines for CE marking and EU commercial release. Le...
Job Role: Validation Engineer. Location. Palo Alto, CA. Contract: W2. Job Description. 6 years of experience as a Validation Engineer. 4 years of experience with Labware LIMS, LabX, etc. Plan, lead, and executed the validation efforts for standalone Lab Instrument Software systems. Responsible for planning, scheduling, and executing validation efforts for LabX and other pharmaceutical systems. Ensures validation is being performed per established...