Regulatory Affairs Specialist

Job Description

As a resident Regulatory Affairs Specialist specifically focusing on FDA, you will serve as a key advisor and strategic consultant, assisting with FDA clinical trial filings, answering FDA’s questions, and providing strategies on product registration and the plan of clinical trials. You are a critical pillar of compliance efforts, as you will ensure FDA compliance with regulatory requirements at each stage of product development and clinical trial timelines.

Responsibilities:

  • Ensure all regulatory requirements are met throughout the product development lifecycle
  • Design and complete FDA clinical trial
  • Prepare 510(k) regulatory applications and 510(k) letters to file to secure/maintain marketing approvals
  • Review advertising and marketing materials, ensure appropriateness and compliance to FDA regulatory requirements
  • Responsible for timely registration of the facility
  • Maintaining current knowledge of FDA and international regulation and standards, as applicable to company products
  • Answering FDA’s questions
  • Dealing with FDA MDR cases
  • Evaluating risks for other international markets, such as EU, UK, Australia, and Canada

Requirements

  • 5+ years experience as regulatory affairs specialist or equivalent, with 3+ years of experience working with FDA clinical filings
  • 510k submission and MDR cases experience required
  • In-vitro diagnostic device (IVD) experience
  • Regulatory Affairs Certification (US or EU) preferred
  • Ability to manage several competing priorities; versatility to work with changing priorities
  • Able to operate autonomously, execute with strong judgment, and thrive in a fast-moving environment
  • Ability to communicate, present, and influence all levels of the organization, including executive and C-level.
  • Experience of working in startups. Strong ability to learn and be flexible.
  • Strong analytical and detail-oriented abilities
  • BA/BS degree or equivalent
  • Regulatory experience with the UK, EU, or Australian market is a plus

What we offer:

  • Competitive hourly the compensation, range is $80-110/hour
  • Opportunity to be converted into a full-time role soon
  • 100% remote role with a rapidly growing startup
  • Versatile tasks and a flexible schedule

 

Submit resume