Telecommute Senior Regulatory Affairs Analyst

Location: California, Georgia, Massachusetts, New Jersey, New York, Washington

Compensation: To Be Discussed

Staff Reviewed: Mon, Sep 06, 2021

This job expires in: 12 days

Job Category: Healthcare

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

A privately-held healthcare technology solutions company is searching for a person to fill their position for a Telecommute Senior Regulatory Affairs Analyst.

Core Responsibilities of this position include:

  • Ensuring that the company’s Quality System is compliant with the relevant current medical device regulations
  • Ensuring that the company’s products have the required medical device premarket clearances and licenses to be sold in these markets
  • Providing subject matter expertise, interpretations and training on applicable medical device regulations

Applicants must meet the following qualifications:

  • Bachelor degree in Computer Science or Computer Engineering or related discipline; or Diploma in Quality Management, Regulatory Affairs, or Operations Management; or Other related education by training or by work experience
  • Minimum 2 years of quality systems experience in medical device industry or an ISO 13485 / 9001 regulated industry, or equivalent
  • Experience in a software development industry preferred
  • Working knowledge of medical device regulations and standards applicable to software medical device products, including: ISO 13485 Medical Device Quality System Requirements
  • Working knowledge of medical device regulations and standards applicable to FDA Quality System Regulation (21 CFR 820)
  • Working knowledge of medical device regulations and standards applicable to ISO 14971 / EN ISO 14971

COMPLETE JOB DESCRIPTION

The job description is available to subscribers. Subscribe today to get the full benefits of a premium membership with Virtual Vocations. We offer the largest remote database online...

BECOME A PREMIUM MEMBER TO UNLOCK FULL JOB DETAILS & APPLY

  • ACCESS TO FULL JOB DETAILS AND APPLICATION INFORMATION
  • HUMAN-SCREENED REMOTE JOBS AND EMPLOYERS
  • COURSES, GROUP CAREER COACHING AND RESOURCE DOWNLOADS
  • DISCOUNTED CAREER SERVICES, RESUME WRITING, 1:1 COACHING AND MORE
  • EXCELLENT CUSTOMER SUPPORT FOR YOUR JOB SEARCH