Regulatory Affairs Consultant

5 days ago

Washington, United States Vision Achievement Limited Full time
Job Description

Job Title: Regulatory Affairs Consultant

Company: Vision Achievement Limited

Location: 100% Remote, in the USA

Job Type: Independent Contractor Role

Client: ELIQUENT Life Sciences

About the Role:

We are seeking a highly experienced Regulatory Affairs Consultant to join our team at Vision Achievement Limited. As a Regulatory Affairs Consultant, you will be responsible for planning and delivering Life Science consulting engagements related to quality/regulatory affairs infrastructure, appropriate to the level of risk in a target product.

Key Responsibilities:

  • Design and implement quality systems planning and implementation, design control, and process validation
  • Develop and submit regulatory submissions, remediation, clinical evaluation, post-market surveillance, and risk management
  • Provide expertise in RA/QA under 21 CFR 2XX and 8XX sections and have wide life sciences experience
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements
  • Travel extensively domestically (25% - 50%) and occasionally internationally

Requirements:

  • Bachelor's degree in Engineering, Science, or a Life Sciences related field
  • Significant experience in RA/QA matters related to one or more of medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics
  • Experience with design and manufacturing, interpretation and application of codes, regulations, and standards, GMP
  • Experience with quality systems planning and implementation, design control, and process validation
  • Experience with submissions, remediation, clinical evaluation, post-market surveillance, risk management
  • Travel ability to travel extensively domestically (25% - 50%) and occasionally internationally

What We Offer:

  • Good rates of compensation, defined by project
  • A top-rated team to work alongside you
  • Flexible work arrangements, seeking variety in the work you do

Person Description:

  • Confident personality and competent in getting ideas across to others effectively
  • Demonstrates ability to work in a team environment, especially when operating remotely
  • Passion for patient or consumer safety through effective regulatory and quality activities
  • Respects the contribution of all colleagues and facilitates consensus on tough issues
  • Demonstrates flexibility in day-to-day working in the team and in approach to unique client issues
  • Established as an independent contractor or contract-for-hire

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