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Description/Comment:

• Plans, coordinates, facilitates, and reports
• Responsibilities may include: - Administration of the companies complaint management program for compliance to corporate requirements
• Assist in the planning and implementing pre-market registration, reporting and compliance activities in accordance with the business plans.
• Assists in the implementation of global regulatory compliance programs for product corrective action and/or adverse event reporting.
• Assist in the preparation of premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.

Educational requirements:

• Bachelors degree in field with 2+ years exp. OR Masters degree in field with 1+ years exp. IVD experience strongly desire.