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About The Position
- Responsible for product and combinations 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 and combinations 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 5 years of experience in regulatory affairs within the medical device industry and Skincare.
- Proven experience with CE marking and Cosmetic regulations and standards.
- Experience with registrations in APAC and LATAM – Nice 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 and under pressure.
- Excellent written and verbal communication skills.
- English full proficiency
Let’s talk about your future
