Array

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

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

Regulatory Affairs Specialist