Senior Regulatory Affairs Specialist

Description: A leading global diagnostics company is seeking a Senior Regulatory Affairs Specialist for their growing team. The Senior Regulatory Affairs Specialist will work closely with the Director of Regulatory Affairs for product approvals in theU.S., EU and other global markets. Responsibilities: - Manages regulatory duties dealing with the development, support, and manufacturing of the Company's medical device products. - Manages and implements regulatory strategies and plans for timely approvals of novel products - Reviews and composes labelling and promotional materials for products - Manages all filing and submission work of 510(k), PMA and/or International registrations - Oversees and assesses Regulatory developments related to the Company's products. Qualifications: - 5+ Years Regulatory Affairs Experience desired - Hands-on submissions experience with II/III medical device company - Experience with 510(k) and/or PMA or International Registrations - Strong collaborative skills and ability to work well in team settings - Must have exceptional communication skills, both verbally and written - Bachelor's Degree (Life sciences or Engineering strongly desired)

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com