Regulatory Affairs Specialist

2 days ago


Washington, United States Vision Achievement Full time
Job Title: Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Vision Achievement. As a Regulatory Affairs Specialist, 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 maintain regulatory submissions, remediation, clinical evaluation, post-market surveillance, and risk management
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements
  • Provide expert advice on regulatory affairs and quality assurance
Requirements:
  • Bachelor's degree in Engineering, Science, or a Life Sciences-related field
  • Significant experience in RA/QA matters related to medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics
  • Experience with design and manufacturing, interpretation and application of codes, regulations, and standards, GMP
What We Offer:
  • Competitive salary package: $125.00 - $225.00 (US Dollar)
  • Opportunity to work with a top-rated team
  • Flexible work arrangements
  • Professional development opportunities

We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, please submit your application.



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