Cochlear pioneered and is the global leader in the research and development, manufacture and marketing of implantable hearing solutions. Cochlear’s global headquarters is located in Sydney, Australia where we design and manufacture the leading cochlear implant devices in the world. A success story in the commercialization of R&D, Cochlear has a 60% share of the global market, employs more than 2,500 people worldwide, operates directly in over 20 countries and sells in over 100 countries. Over 250,000 people across more than 100 countries now experience hearing as a recipient of a Cochlear hearing solution.
Post : Regulatory Affairs Specialist
About the role
In order to help Cochlear bring new products to market and support cochlear implant recipients we are recruiting for a Regulatory Affairs Specialist I in our Americas head office based in Centennial, CO. To be successful in this role, you’ll be able to assemble and prepare paper and electronic submissions for regulators and participate in the internal content review board. You’ll work collaboratively with colleagues in the Clinical, Marketing, and Operations departments to help bring new products to market and satisfy the requirements of our regulatory bodies. In this role you'll have the opportunity to make a significant contribution to Cochlear's successful history of innovation by applying your knowledge of the health sciences and strong communication skills. You'll know you've been successful in this role when you've helped ensure compliance with regulatory requirements while establishing and growing your career in Regulatory Affairs
Job Description
• Assemble and prepare submissions to regulators
• Coordinate post-approval reporting obligations
• Participate in Content Review Board
• Maintain licenses and registrations
• Provide operational and administrative support
• Provide assistance and support field actions, including acting as the recall coordinator
Candidate Profile
• Bachelor’s degree in Health Sciences or equivalent work experience
• Strong written and verbal communication skills
• Computer literate with Microsoft Office knowledge (Word, PowerPoint and Excel)
• The ideal candidate will have prior experience in life sciences and within a regulated industry (Medical Devices, Pharmaceuticals, etc.)
Additional Information
Qualification : Bachelor’s degree
Industry Type : Pharma
Location : Centennial
Job no : 608438
Functional Area : Regulatory Affairs
End Date : 15th May, 2018
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