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Regulatory Affairs Specialist

1 month ago

Mumbai, Maharashtra, India ITEX Full time

About ITEX: As a global leader in producing high-tech medical and aesthetic devices, we are committed to innovation and excellence. Our company has offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries, making us a truly international organization.

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

Key Responsibilities:

  • Ensure regulatory compliance of medical devices across different countries
  • Coordinate and prepare product registrations and notifications within deadlines
  • Communicate with regulatory authorities for product registrations and updates
  • Prepare and maintain technical files and other regulatory documents
  • Legalize documents and certificates through notary offices and 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
  • Handle 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
  • Ensure compliance with organizational quality, environment, and health and safety standards

Requirements:

  • Academic degree in life sciences, chemistry, or technical/engineering education
  • 2+ years of experience in a similar regulatory affairs position
  • Knowledge of regulatory issues and experience interfacing with local and international regulatory bodies
  • Advanced computer skills (MS Office)
  • Experience in medical writing is an advantage
  • English: Advanced (C1)
  • Slovak: Proficiency (C2)

What We Offer:

  • Competitive salary
  • 13th salary in Q1 based on both company profits and individual employee performance
  • Reimbursement for commuting expenses
  • Great office environment and team culture
  • Long-term contract with the potential for growth

Contribute to our mission: As a Regulatory Affairs Specialist, you will be part of a dynamic team that is shaping the future of medical and aesthetic devices. If you are passionate about regulatory compliance and have a strong background in life sciences, we encourage you to apply for this exciting opportunity.