IT Project Manager

Location: Santa Clara, CA and various unanticipated locations throughout the U.S.
Multiple positions available

Job Description:

Analyze the new Medical Device Regulations (MDR) and compare against the Medical Device Directive (MDD) standards to identify key changes and plan for potential actions of remediation. Interact with key stakeholders from global business units and identify impacted products. Develop MDD to MDR transition strategy based on current CE Certification validity and commercial forecast. Work with product, regulatory and clinical teams to finalize product requirement gaps with respect to new Medical Device Regulations (MDR). Develop remediation plans. Roll out project strategy and schedules through a formal kickoff meeting. Initiate process and document workflows. Work with product and regulatory teams to implement design documents and labeling updates. Work with labeling function for the labeling artwork, translations, and release. Work with Global Medical Affairs to develop clinical documents. Update Design History File (DHF) to enable the product for notified body audit. Conduct final design review with MDD to MDR Transition plan. Prepare Summary of Technical Documentation (STED) to support Declaration of Conformity sign off for CE certificate renewal to implement product in the market. Work with Global Regulatory to initiate rest of the world product approvals. Work with marketing team and roll out the strategy for product implementation. Conduct periodic core team meeting and Senior Management Review (SRM) meeting to review milestone status and progress. Travel and work at client sites as assigned.

Job Requirements:

Requires Bachelors degree or foreign equivalent in Computer Science, Engineering (Any), Information Technology, Computer Technology, Engineering Design Technology, Computer Information Systems, Management Information Systems or related field plus two (2) years of experience in the job offered, or related IT or engineering role. Employer will accept a combination of education and experience as determined by a qualified evaluation service as equivalent to a Bachelor's degree. Base Salary: $88,483 - $90,000/Year (whatever range we reasonably expect to hire a candidate within based upon our internal salary grid). Exact compensation may vary based on skills, experience, education, and/or to comply with federal or state law. Travel and work at client sites as assigned.

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