Medical Device Compliance Specialist
hace 2 días
About Itex: As a global leader in producing high-tech medical and aesthetic devices, we are committed to delivering innovative products that meet the highest standards of quality and safety. Our international presence spans across the USA, UK, Bratislava, India, and other countries, allowing us to stay at the forefront of innovation in our field.
Job Overview: We are seeking an experienced Medical Device Compliance Specialist to join our team. In this role, you will play a crucial part in ensuring that our medical devices comply with all applicable regulations and standards across various markets. Your work will directly contribute to the global market access of our innovative medical and aesthetic devices, ensuring product safety and regulatory integrity.
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
- Maintain technical files and other regulatory documents
- Liaise with customers to provide product data and regulatory information
Requirements:
- 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)
We Offer:
- Competitive salary: $80,000 - $110,000 per year
- 13th salary in Q1 based on company profits and individual performance
- Reimbursement for commuting expenses
- Great office environment and team culture
- Long-term contract with potential for growth
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