Responsibilities: Provides regulatory support for in vitro diagnostic product reagent manufacturing. Assesses regulatory impact of design and manufacturing process changes and, as needed,
prepares/submits 510(k)s, PMA 30 Day notices and supplements, updates to IVDD documentation and prepares 510(k) notes to file. Communicates changes to Regional RA teams as needed. Prepares and submits PMA annual reports and information for Canadian license renewals. Maintains awareness of global regulatory legislation and assesses impact of changes to the business. Participates in audits and inspections by regulatory authorities and certification/accreditation bodies.
Requirements: Strong leadership, interpersonal, communication and organizational skills required. Must possess a high level of critical and strategic thinking skills and be a detail oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities. Must be able to set priorities as well as adapt to changing priorities. Experience with U.S. FDA 510k and/or PMA submissions and interaction with FDA reviewers required. Knowledge and experience with global registrations and development of in vitro diagnostic medical devices a plus.
Job ID: 191143
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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