Senior Regulatory Affairs Specialist - PMA products
Fall River, MA
Special referral bonus for this job:
$500 Referral Bonus OfferedThe Senior Regulatory Affairs
Specialist for this established, yet highly innovative
medical technology company will manage activities for assigned
projects and participate as a lead regulatory representative on
core teams and develop and implement regulatory submission
strategies.
Requirements:
Extensive and thorough knowledge of regulations/guidelines governing development of medical devices including Quality Systems requirements and the ability to mentor and guide others in the application of these principles.
Demonstrated experience having primary responsibility for regulatory submissions, 510K, PMA and/or IDEs including successful FDA interface and negotiations.
Expertise in development, review, and approval of labeling and promotional material.
Must have knowledge of the U.S.A. Federal Regulations for medical devices including those applicable to the import/export of devices.
Exposure and knowledge with the requirements for medical device registration/licensing in the EU, Japan, Canada, Australia, Latin America and Asia/Pacific.
Must have exceptional written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers.
Must be able to travel occasionally to meet with customers / project teams.
Education: B.A./B.S. or advanced degree in scientific/life-sciences or engineering field with applicable industry experience and direct regulatory affairs experience with particular focus on U.S. FDA.
Experience: 3+ years of relevant medical device industry, Regulatory Affairs experience. Additional competency and exposure in clinical affairs and clinical research planning is a plus.
Requirements:
Extensive and thorough knowledge of regulations/guidelines governing development of medical devices including Quality Systems requirements and the ability to mentor and guide others in the application of these principles.
Demonstrated experience having primary responsibility for regulatory submissions, 510K, PMA and/or IDEs including successful FDA interface and negotiations.
Expertise in development, review, and approval of labeling and promotional material.
Must have knowledge of the U.S.A. Federal Regulations for medical devices including those applicable to the import/export of devices.
Exposure and knowledge with the requirements for medical device registration/licensing in the EU, Japan, Canada, Australia, Latin America and Asia/Pacific.
Must have exceptional written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers.
Must be able to travel occasionally to meet with customers / project teams.
Education: B.A./B.S. or advanced degree in scientific/life-sciences or engineering field with applicable industry experience and direct regulatory affairs experience with particular focus on U.S. FDA.
Experience: 3+ years of relevant medical device industry, Regulatory Affairs experience. Additional competency and exposure in clinical affairs and clinical research planning is a plus.
