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About The Position
- Responsible for product submissions, global registrations and communication with authorities
- Prepare and maintain technical documentation and regulatory files in compliance with applicable standards
- Ensure compliance with global regulations, standards and guidelines
- Assist in the development of regulatory strategy and updates strategy based upon regulatory changes
- Assess the impact of any product changes, process modifications, or updates to existing regulations and manage notifications of change
- Support Product development projects from Regulatory perspective
- Provide training and support to internal teams on regulatory requirements and best practices
- Support audits (both external & internal) presenting Regulatory materials and with Regulatory inquiries
- Review and update as necessary promotional material, labelling and SOPs for compliance with local and global regulations
- Recognize potential compliance problems areas and make recommendations to resolve
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related field. Advanced degree preferred
- Minimum of 4 years of experience in regulatory affairs within the medical device industry
- Proven experience with CE marking
- Experience with registrations in APAC and LATAM - Advantage
- Strong knowledge of EU MDR- Experience in submission is an advantage, and other relevant regulatory requirements
- Strong attention to detail and ability to work independently
- Excellent written and verbal communication skills
- English full proficiency
- Market access
Let’s talk about your future
