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Regulatory Affairs, Senior Manager

Employer
Perkin Elmer
Location
Waltham MA US
Closing date
May 12, 2017

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Sector
Pharmaceutical
Hours
Full Time
Organization Type
Corporate
Summary:

PerkinElmer is a global technology company focused on improving the health and safety of people and the environment. The Regulatory Affairs Senior Manager 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:
  • 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,
  • Development of regulatory plan for US submission and/or global regulatory plan 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 guidances, monitor development of regulations and communicate impact to the business
  • Provide input and feedback on clinical study protocols to ensure US regulatory requirements are incorporated
  • Act as FDA liaison for US submissions and other interactions regarding regulatory matters, including preparing for and attending meetings with the FDA as required
  • Support CE marking activities for US manufactured IVD products
  • Review and approve promotionalmaterials and product labeling
  • Prepare USDA importation / exportation permits
  • Prepare export notification to FDA
  • Manage the day-to-day activities of the Regulatory Product Release system (product classification, set up of licences, release of orders, etc.)

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