Sr. Regulatory Affairs Specialist - Biomet - Palm Beach Gardens, FL
• Develop, submit and maintain product registrations/submissions in global markets for line extensions and new product releases. Product registrations include current markets such as: US, Europe, Canada, Australia, Mexico, Russia and Japan.
• Support each BIOMET 3i subsidiary/distributor on a case-by-case basis to address product registrations/submissions, custom requirements, and negotiations with ministries of health in each respective country.
• Review and approve all labeling including product labels and Instructions for Use before publication and/or release.
Qualifications:
• Bachelor’s degree in health or science related field, minimum of five (5) years of practical medical device regulatory experience; or possess a Masters Degree from a Regulatory Affairs program and equivalent experience.
• The individual must demonstrate in-depth working knowledge of Global regulatory regulations and ability to interpret them, and be knowledgeable about how to monitor changes in regulations.
• Must have analytical skills, be detail oriented and have ability to work collaboratively with cross functional teams.
• Bi-lingual preferred
Biomet is an EEO / Affirmative Action Employer - M/F/Disability/Veteran
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