Required Regulatory Affairs Specialist.
* 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: * Bachelors 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.
This position is open to all candidates.
