Regulatory Compliance Specialist

hace 1 día


Buenos Aires, Buenos Aires C.F., Argentina ITEX A tiempo completo

About ITEX: Our company is a leading global developer of cutting-edge medical and aesthetic devices. We have offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries.

**Job Overview:** As a Regulatory Affairs Specialist, you will play a critical role in ensuring that our medical devices comply with all applicable regulations and standards worldwide. This position requires close collaboration with regulatory bodies, internal departments, and customers to manage product registrations, maintain technical documentation, and support compliance processes.

Key Responsibilities:

  • Evaluate and ensure regulatory compliance of medical devices across various markets
  • Coordinate and prepare product registrations and notifications within deadlines
  • Communicate with regulatory authorities for product registrations and updates
  • Develop and maintain technical files and other regulatory documents
  • Obtain notarized documents and certificates through embassies for product approvals
  • Provide support to customers with product data and regulatory information
  • Ensure compliance for product exports, including managing Certificates of Origin
  • Collaborate with marketing, purchasing, and engineering teams to meet regulatory requirements
  • Promote the issuance of Free Sale Certificates and other required regulatory documents
  • Support the registration of Economic Operators in the EUDAMED database
  • Translate regulatory documents between Slovak and English when necessary
  • Guarantee compliance with organizational quality, environment, and health and safety standards

Requirements:

  • Bachelor's degree in life sciences, chemistry, or technical/engineering education
  • At least 2 years of experience in a similar regulatory affairs position
  • Familiarity with regulatory issues and experience interacting with local and international regulatory bodies
  • Advanced computer skills (MS Office)
  • Experience in medical writing is an asset
  • English: Advanced (C1)
  • Slovak: Proficiency (C2)

We Offer:

  • Competitive salary, estimated at $65,000 per year
  • 13th salary payment in Q1 based on both company profits and individual employee performance
  • Reimbursement for commuting expenses
  • A great office environment and team culture
  • Long-term contract with potential for growth


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