Regulatory Affairs Expert Skincare & Injectable

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Alma Lasers LinkedIn

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