Regulatory Affairs Specialist Job in PerkinElmer at Mumbai

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