Life Sciences Regulatory Consultant

Jobot

Job Description

This role is remote with up to 50% travel to client sites (currently no travel required due to Covid)

This Jobot Job is hosted by: Kyle Shaw
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
Salary: $150,000 - $185,000 per year

A bit about us:

We are a IoT / Automation consultancy that builds "self-driving" manufacturing capabilities for businesses in a variety of industries. We believe in providing our clients with exceptional technical solutions, and work closely with their internal teams to understand business needs and deliver the highest quality products possible.

We are seeking a Regulatory Compliance / Quality Management Systems Consultant to join our team to work with clients in the medical device space to help solve challenging Regulatory and Compliance issues for Regulatory Tracking, Submissions, and Unique Device Identification (UDI) challenges. This is a fast-paced environment in which you'll act as a consultant and solutions-provider in a client-facing position.

We are looking for someone with 5+ years of professional experience with the following background:

  • Strong knowledge of regulatory compliance / quality management systems, specific to the medical device field preferably
  • 2+ years experience as a leading Regulatory Information Management (RIM) or UDI consultant
  • Knowledge of ISO 13485 standards and good understanding of IMDRF requirements.
  • Understanding and knowledge of medical device regulations in both the US as well as globally
  • Consulting or client-facing experience is a major plus
  • Strong communication skills
  • Experience in fast-paced environments
  • Problem solver who can provide advice and strategies across business levels


Why join us?

We have a fantastic culture that prides ourselves on innovation and collaboration. We work with innovative and leading companies, and are a group of thought leaders that love bringing new solutions to the businesses we partner with.

We have a great compensation package, offering competitive base pay + utilization bonuses + annual company performance bonuses. Additionally we have health insurance, 401k, and unlimited PTO.

Our team is spread across the US and you'll have the opportunity to work remotely while travelling as needed to client sites up to 50% (currently we do not require any travel due to Covid-19).

Job Details

Responsibilities:

  • Meet and support client needs while acting as an ambassador for the firm
  • Solve Regulatory and Compliance issues for Regulatory tracking, submissions, and unique device identification (UDI) challenges
  • Conduct application design to support business processes in diverse tech environments
  • Design and configure RIM and UDI software solutions
  • Train clients in RIM and UDI concepts and RIM software tool capabilities
  • Define Data Cleansing programs for clients


Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.

Job Requirements

 

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