Sr. Regulatory Affairs Specialist Opportunity - Medical Device - Santa Clarita, CA
POSITION REQUIREMENTS:
·
BA/BS or MS degree in Life Sciences,
Engineering, or health care-related discipline
·
5+ years of experience in the medical device
industry
·
preferably in a small manufacturing/R&D
environment
·
experience with medical writing, clinical
studies, regulatory submissions, and regulatory reviews
·
Must have experience developing, writing, and
organizing all aspects of the IDE/PMA/510(k)'s and CE Submissions
·
Ability to independently analyze and interpret
novel clinical, medical and scientific data
·
Current knowledge of current U.S. FDA and global
(Canada, Australia, European Union, Latin America, India, China, etc.)
regulatory requirements within the medical device industry.
·
Excellent organizational skills and attention to
detail
·
Strong analytical, management, communication and
interpersonal skills. Good knowledge of MS Office, Internet, databases, etc.
·
Ability to work with minimal supervision in a
busy environment
·
Excellent writing skills and the ability to
write scientific summaries
·
Must be able to handle multiple assignments and
perform in a diverse cross-functional team environmentContact me for details!Rachel Carey - rcarey@clintelservices.com
·
BA/BS or MS degree in Life Sciences,
Engineering, or health care-related discipline
·
5+ years of experience in the medical device
industry
·
preferably in a small manufacturing/R&D
environment
·
experience with medical writing, clinical
studies, regulatory submissions, and regulatory reviews
·
Must have experience developing, writing, and
organizing all aspects of the IDE/PMA/510(k)'s and CE Submissions
·
Ability to independently analyze and interpret
novel clinical, medical and scientific data
·
Current knowledge of current U.S. FDA and global
(Canada, Australia, European Union, Latin America, India, China, etc.)
regulatory requirements within the medical device industry.
·
Excellent organizational skills and attention to
detail
·
Strong analytical, management, communication and
interpersonal skills. Good knowledge of MS Office, Internet, databases, etc.
·
Ability to work with minimal supervision in a
busy environment
·
Excellent writing skills and the ability to
write scientific summaries
·
Must be able to handle multiple assignments and
perform in a diverse cross-functional team environmentContact me for details!Rachel Carey - rcarey@clintelservices.com
