Senior Quality Consultant Position Open

Há 3 dias

Brasil beBeeRegulatory Tempo inteiro R$65.000 - R$86.000

Senior Quality Professional Job Description:

We are seeking a Senior Quality consultant to provide expert advice and guidance on regulatory compliance, quality management systems, and technical documentation.

Key Responsibilities:

  • Provide regulatory consulting services, including research and preparation of regulatory classification and strategy/pathway reports, review and identification of gaps in technical/regulatory documentation, and preparation of premarket submissions to regulatory authorities.
  • Perform literature searches and prepare Clinical Evaluation Reports, assist in addressing and responding to deficiencies of product submissions identified by regulatory authorities, and provide guidance on testing requirements to support marketing submissions.
  • Implement quality management systems (QMS) and conduct internal audits/supplier audits for manufacturers, distributors, and vendors.
  • Maintain and update QMS with additional requirements, review and advise on labeling and marketing materials, including written documents and website.

Requirements:

  • 5+ years of experience in IVD regulatory affairs.
  • Knowledge of IVD regulatory requirements for the Brazil Market (Brazil RDCs).
  • Experience with international medical device and IVD regulations is an advantage.
  • Strong interpersonal skills and ability to work with all levels of a client's organization.
  • Commitment to excellence in deliverables and customer service.
  • Effective technical writing skills.
  • Ability to identify, understand, and resolve issues.

What We Offer:

  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • Recognition and rewards for outstanding performance.

Why This Role Matters:

By joining our team as a Senior Quality consultant, you will play a crucial role in ensuring the highest standards of quality and regulatory compliance. Your expertise will help us make a positive impact on people's lives and contribute to the advancement of medical technology.

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