Business Professional - Regulatory Affairs Specialist

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, Smart Sheet, Agile, Master Control, Oracle. Self-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.