Clinical Regulatory Affairs Specialist

  • Jobot,
  • Lynn, MA
  • 2 hours ago
FDA, Consulting, ISO, Quality, Systems, Research, Medical Device, Development, Analytical, Protocols, Database, Data Collection, Project, Management
Full Time
$125,000 - $160,000 per year

Job Description

Top FDA Regulatory Consulting Firm seeks a Regulatory Affairs Specialist!

This Jobot Job is hosted by: Joe Thompson
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $125,000 - $160,000

A bit about us:

We provide clients with unparalleled FDA/ISO Regulatory consulting, Quality Systems support, Point-of-Care Analyzer Training services, and Market Research & Go-to-Market guidance. We work with both large and small companies, manufacturing and distributing medical devices and in vitro diagnostic products and instruments. Want to join one of the top up-and-coming Regulatory Advisory companies? Read on!

Why join us?
  • Opportunity to influence the Medical Device Market.
  • Amazing benefits including health/dental, HRA, and 401k with MATCH.
  • Work/life balance.
  • Opportunity for Advancement.

Job Details

***Provide regulatory guidance to study sponsors and IVD medical device manufacturers. Responsible for the overall planning and direction of clinical affairs and regulatory activities. Develops and implements strategies in a collaborative environment between colleagues and clients with the goal of successful regulatory submissions.***

  • New Client/Sponsor on-boarding including attending client conferences, defining project scope and development of project proposals.
  • Development of U.S. Food and Drug Administration (FDA) Pre-Submission, Informational Meeting or Determination Meeting Submissions.
  • Assist in the creation of Clinical and Analytical Study Protocols, Informed Consent Forms (ICFs), Study Database, and Data Collection Forms in conjunction with assigned Project Managers.
  • Assist with Institutional Review Board (IRB) submissions in conjunction with assigned Project Managers.
  • Development, compilation, review and submission of Regulatory Filings such as FDA 510(k), de novo and PMA submissions, Health Canada Licensure, EU Technical Files, etc.
  • Interaction with regulatory agencies and Sponsors throughout the submission and review processes.

  • Bachelor's degree in a health care or other scientific discipline or educational equivalent.
  • 5-10 years Clinical Trial Management and/or Regulatory Affairs experience.
  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and HIPAA guidelines.
  • Understanding of U.S. Food and Drug Administration (FDA) laws and guidance.
  • Understanding of Health Canada Licensing Requirements and the EU IVDR.
  • Understanding of IRB guidelines and Common Rule.
  • 15-20% Travel including local, within U.S and outside of the US.

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Dice Id : 91113390
Position Id : 823545998
Originally Posted : 2 months ago
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