PerkinElmer
Regulatory Affairs Specialist
PerkinElmer
is a global technology company focused on improving the health and safety of
people and the environment. The
Regulatory Affairs Specialist will support our Diagnostics Business that
focuses on products targeted to improve human health. He/she will represent regulatory submissions
on global cross-functional teams providing guidance on US regulatory
requirements, review data for sufficiency and lead registration related
negotiations.
Key Responsibilities:
Support
preparation and timely completion of FDA submissions for in vitro diagnostic
devices (assays, instruments, software) to meet project and business needs
(Pre-Submission, 510(k), de Novo, PMA supplement, PMA annual report, etc.)
Participation
on cross functional project teams to provide strategic and tactical guidance to
meet US FDA requirements,
Support
development of regulatory strategy for US submission and/or global regulatory
plans for US manufactured IVD products
Assessment
and applicable documentation of changes in product, manufacturing processes,
labeling affecting IVD products distributed in the US, including communication
to global Regulatory and project teams for impact assessment
Support
global Regulatory teams and/or in-country dealers/representatives with
regulatory registrations of US manufactured IVD products
Maintain
up-to-date knowledge of US IVD regulations and applicable guidance’s, monitor
development of regulations and communicate impact to the business
Support
CE marking activities for US manufactured IVD products
Support
day-to-day activities of the Regulatory Product Release system (product
classification, set up of licences, release of orders, etc.)
Qualifications:
Bachelor’s
degree in life science related field (Medical Technology, Clinical Chemistry,
Biology)
Minimum
of 1 years of experience supporting FDA submissions for IVD and/or medical
devices
Understanding
of FDA regulations and guidance documents required
Previous
experience supporting international registrations
Limited
travel (up to 10-15% of the time, or as circumstances dictate)
Good
interpersonal, verbal and written communication skills (in English)
Excellent
time management, organizational, negotiation, and problem solving skills
Ability
to work independently
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