Regulatory Affairs Specialist - Senior

Title: Senior Regulatory Affairs Specialist
Duration: 12 Months Contract with possible extension
Location: Chaska, MN- 55318
Pay: $52.81 /hr. on w2- no benefits

Job Description

The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on Beckman Coulter regulatory programs. The incumbent's primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities.

Responsibilities may include:

·         Administration of the company's complaint management program for compliance to corporate requirements.

·         Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans.

·         Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.

·         Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.

·         Additionally, may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.

·         Functioning as a team expert for promotional materials review, experimental designs, data analysis and product labeling as they relate to registration and commercialization of medical devices.

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Educational Requirements

·         Bachelor's degree in field with 5+ years of experience, OR Master's degree in field with 3+ years of experience.

·         Medical Technologist background and IVD experience strongly desired.