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Regulatory Affairs Specialist Jobs in Mumbai - PerkinElmer

Regulatory Affairs Specialist

PerkinElmer
Expired

Posted: 25 Feb 21

Job Description

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

Job Particulars

Role hr admin
Who can apply Experienced (1 Years)
Hiring Process Face to Face Interview
Employment Type0
Job Id1129119
Locality Address
Country India

About Company

PerkinElmer
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