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Principal Regulatory Affairs Specialist

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    Location(s)
  • Waltham, MA

Status Regular Job ID JR-010146 Recruiting Region Americas

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 promotional  materials 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.)

Qualifications:

  • Bachelors Degree in life science related field (Medical Technology, Clinical Chemistry, Biology)

  • Minimum of 3 years of experience in managing all aspects of preparing and filing FDA submissions for IVD and/or medical devices and overall 5 year direct industry experience

Desired:

  • Excellent understanding of FDA regulations and guidance documents required
  • Previous experience supporting international registrations (FDA, CE) required
  • RAC certification preferred
  • Limited travel (up to 10-15% of the time, or as circumstances dictate)
  • Excellent interpersonal, verbal and written communication skills (in English)
  • Excellent time management, organizational, negotiation, and problem solving skills
  • Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management
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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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