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Sr. Regulatory Affairs Consultant in Bothell, WA at Eliassen Group

Date Posted: 12/31/2018

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    Bothell, WA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    12/31/2018

Job Description

Sr. Regulatory Affairs Consultant

We have an excellent opportunity available for a Senior Regulatory Affairs Consultant with one of the most respected companies in the Life Sciences industry. Our client is a multi-billion dollar leader in the manufacturing of innovative products in the Medical Device space.

If you are passionate about making an impact with a company, who's goal it is to improve the quality of life for millions of people, we'd like to talk with you! 

This is a contract position that is expected to last for, at least, 12 months.  

In this role, you will be responsible for:

  • Supporting Regulatory Compliance by performing the required activities that assure compliance with FDA regulations for class III products.
  • Being a subject matter expert in Regulatory Affairs for new products
  • Establishing licenses, maintaining files, communicating changes, evolving regulatory landscape, and quality system procedures.
  • Handling or supporting regulatory requests from regulatory agencies, preparing and submitting product registrations and submissions to FDA and other regulatory bodies.
  • Work fluidly across several different business areas including R&D, Manufacturing, Quality Assurance, Marketing and international geographies to develop a regulatory strategy for the business.
  • Reviewing and approving engineering changes, advertising, promotional items and labeling for Regulatory Compliance.

You will be required to have:

  • Extensive experience in the Medical Device Industry.
  • Experience in both international and domestic regulatory submissions.
  • Experience in providing significant Regulatory support to PMA activities.
  • Minimum of a Bachelor’s Degree, Master’s preferred.

About EG Life Sciences:

EG Life Sciences is a professional services firm that delivers flexible and scalable solutions to Medical Device, Pharmaceutical and Biotechnology companies, including the resources they need to meet the unique challenges of FDA regulations and submissions. We offer our consultants Medical, Dental and Vision benefits, as well as 401k and disability and life insurances.