Regulatory Affairs Specialist-01+ Year Contract-$50/hr on W2 RC

Title: Regulatory Affairs Specialist

Location: Chaska, MN: 55318

Contract: 01+ Year

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.
• Educational requirements: Bachelor’s degree in field with 5+ years exp. OR Master’s degree in field with3+ years exp.
• Medical Technologist background and IVD experience strongly desired.

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.