Business Professional - Regulatory Affairs Specialist

The Regulatory Affairs Specialist will join existing team and provide support for International Registration of IVD products.


Tasks will include
• Initiation, collection, and coordination of information of regulatory documents for various purposes.
• Preparation and maintenance of product technical files for CE marking. Experience of EU IVDR or MDR a plus
• Organization and preparation of documents for international submissions, including drafting reports, and preparing documentation for submissions
• Coordination with international counterparts to obtain product approvals and renewals.
• Maintaining logs and trackers.
• Organize, update, and maintain regulatory documentation in accordance with department and company procedures.

Required Qualifications and Experience:
• Minimum BS or equivalent education with 1-3 years of relevant experience in Regulatory Affairs or Quality Assurance. Science background preferred.
• Excellent writing skills, and an ability to generate clear, concise documents
• Strong planning and organizational skills.
• Proficient with computer and standard software programs, especially Excel, Word, Abode Pro, Teams, SmartSheet, Agile, Master Control, Oracle.
• Self-starter starter, with the ability to work and learn independently.
• Strong attention to quality/detail.
• Ability to handle multiple tasks and priorities.
• Excellent organizational, time management, and administrative skills.

This is an on-site position but can be hybrid for right candidate.
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