Regulatory Affairs Specialist Job in PerkinElmer at Mumbai

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