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Global Compliance Lead - Consumer Medical Devices

Company: Murdoch Mason Executive Search Group
Location: Princeton
Posted on: August 6, 2022

Job Description:

We are exclusively partnered with our successful Consumer Products/Goods client to find the first Global Compliance Lead, Medical Devices. This company owns well-known CPG brands and operates in a multi-site manufacturing plant environment, including for regulated products. Awesome entrepreneurial culture at a company that genuinely cares about the people. This is a NEW position.You will be the go-to person in the company when there are any questions about regulatory compliance for any medical devices. You will also be the point person for certifying bodies and authorities. Must be hands on. Manage complex processes. Work cross-functionally. Very autonomous.You will oversee the medical device auditing and inspection program globally. You'll also support regulatory agency global audits (FDA, HC and International Authorities) and certifying bodies (ISO, GMed) which includes inspection readiness, inspection conduct, and inspection responses for all medical devices globally. You will lead global regulatory standards management.This is an important, exciting job. And it will be a lot of fun.No direct reports for this role (for now, might be in the future), but you will act as an internal consultant and partner throughout the organization. Big visibility and opportunity to lead change through influence.Required Experience

  • Must have medical device product experience, including building design history and technical files for submission
  • At least 8 combined years of experience in medical devices, including quality assurance, regulatory compliance, and/or R&D
  • Excellent knowledge of regulations governing medical devices, specifically device regulations in U.S., Canada, UK, Europe, Australia, as well as standards ISO 13485, ISO 14971, MDSAP, MDD, IVD, MDR, IVDR
  • Designs control, design history files, and all assessments to perform to deliver a good medical device on the market
  • Proven collaborator, communicator, and valued internal partner
  • Bachelor's degree or equivalent (graduate degree a plus, but not required)Based in Princeton, NJ, would need to be in commutable distance or willing to relocate. The role will be > 50% remote. Flexible remote arrangements can be discussed, with regular visits to the office. Paid relocation.No visa sponsorship available for this position.Please share your interest, and our managing partner Aaron Cleavinger will personally review your application. We can tell you all about the company and position on the first call.

Keywords: Murdoch Mason Executive Search Group, Trenton , Global Compliance Lead - Consumer Medical Devices, Healthcare , Princeton, New Jersey

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