Remote Senior Regulatory Affairs Specialist

Location: Nationwide

Compensation: Salary

Staff Reviewed: Fri, Jun 11, 2021

This job expires in: 28 days

Job Category: Healthcare

Remote Level: 100% Remote

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors, Masters

Job Summary

A company that manufactures and sells device-based medical therapies has an open position for a Remote Senior Regulatory Affairs Specialist.

Individual must be able to fulfill the following responsibilities:

  • Defining the regulatory strategy and manage regulatory submission activities for new technologies and product modifications, considering both domestic and international regulations
  • Managing multiple projects and prioritize tasks on day by day basis to meet project schedules
  • Evaluating information on competitive technologies as necessary to identify appropriate predicate or comparable devices to be included in support of regulatory submissions

Applicants must meet the following qualifications:

  • Bachelor's Degree and a minimum of 4 years of medical device regulatory experience, or adavnced degree and a ninimum of 2 years of medical device regulatory experience
  • Experience authoring regulatory submissions (e.g., 510(k), EU Technical Files/Design Dossiers)
  • Solid interpersonal, analytical, writing, and organizational skills, including the ability to “navigate the grey”
  • General understanding of product development process and design control through knowledge of US FDA and international medical device regulations
  • Prior direct involvement with product development teams
  • Experience with FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

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