QA / Ra Associate - Cape Town, South Africa - Zeal HR

Zeal HR
Zeal HR
Verified Company
Cape Town, South Africa

1 week ago

Thabo Mthembu

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Thabo Mthembu

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Description

An excellent opportunity has become available within the medical device industry, for a QA / RA Associate based in Cape Town.


Responsibilities:


  • Assist in obtaining and maintaining approvals for the medical devices at the Company by ensuring regulatory requirements are known and met within the company
  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits, and inspections
  • Compile and review technical documents as required for regulatory submission
  • Compile and review documents required as part of clinical trial planning and execution
  • Report trial data, statistical analysis, as required by regulatory bodies
  • Wherever necessary assist to compile technical reports
  • Leads or compiles all materials required in submissions and future license renewal and annual registrations.
  • Keeps abreast of regulatory procedures and changes
  • May direct interaction with regulatory agencies on defined matters
  • Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance
  • Champions Design Phase Compliance
  • Providing design teams with regulatory guidance into decision making
  • Regulatory gap analysis
  • Compliance Navigator Profile updates based on regulatory and/or standards updates
  • Assist with design reviews
  • Assisting D&D regarding internal and external audit
  • Technical File collation
  • Risk Analysis process adherence
  • Assess project data, methods, and research findings according to regulatory requirements

Requirements:


  • 3year Technical Bachelor's Degree in either a scientific field or Engineering (Physics, Chemistry, Biotechnology, Engineering, etc.)
  • 2 years' experience in a similar environment / regulatory role
  • Knowledge of Medical device regulations and requirements
  • Knowledge of Comprehensive understanding of Regulatory Affairs and Regulatory bodies
  • Knowledge of Implementation of ISO 13485
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