Senior Regulatory Affairs Specialist (authoring or reviewing (K) remote/virtual work from any US

  • Anywhere

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Location :
Milwaukee, Wisconsin

Expiry Date :
Wed, 14 Apr 2021 23:59:59 GMT

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Description :
Senior Regulatory Affairs Specialist (authoring or reviewing 510(K) remote/virtual work from any US Description Hillrom’s Front Line Care (FLC) business unit products enable earlier diagnosis and treatment. The sooner the diagnosis-the more options for effective treatments. Our smart screening devices and diagnostic tools empower clinicians and health systems to identify and treat every patient with confidence, shortening the path to assessment and then to care. The portfolio includes products for vision screening & diagnostics which focus on preventing blindness by facilitating early detection and treatment; physical exam & diagnostic tools; diagnostic cardiology connected electrocardiograph products; and Hillrom’s respiratory care portfolio. The Role: The Sr Regulatory Affairs (RA) Specialist is responsible for the regulatory strategy for the Front Line Care portfolio including vision care and physical exam devices which includes software, artificial intelligence and software as a medical device (SaMD). This position supports new and sustaining product development teams. The Sr RA Specialist will identify applicable performance and safety standards and will assist product development teams in the creation and maintenance of technical documentation, providing a basis for successful product registrations globally. Effective collaboration with regional Regulatory Affairs colleagues and OUS/CA registration peers is essential. S/he is directly responsible for US and Canadian licensing. Reporting Relationship: The Sr RA Specialist is an individual contributor who reports to the Regulatory Manager, Front Line Care. Essential Duties: + Provide global performance and safety requirements as an input to product design teams + Manage registration plans through collaboration with global RA peers + Direct safety agency test planning and execution + Review scientific/engineering materials (protocols/reports) + Review and approve test compliance reports and associated technical documentation + Review product labeling including advertising and promotional material for compliance + Prepare presubs, IDE’s and premarket clearance applications for USA + Prepare license applications and technical documentation for Canada + Support OUS/CA product registration teams + Provide regulatory assessment on proposed changes to marketed devices + Facilitate communication and tracking of changes to regulations and standards by maintaining a library of information Support continuous improvement activities + Fulfill other requests as needed by the busines Location: This role can be located at our FLC primary office facility in upstate NY outside of Syracuse (Skaneateles Falls) or other Hillrom office location including Chicago, IL; St. Paul, MN; Milwaukee, WI; Cary, NC. Consideration will also be given to remote/virtual work. Qualifications Experience and Qualifications: + Bachelor’s degree is required. Healthcare, Engineering or a related Science discipline preferred; Masters’ degree is desired. + Minimum 5 years’ experience required; regulatory affairs and/or product development in medical devices highly preferred + Experience with Premarket 510(K) submissions is required. + Experience with SAP ECC6/EHP7 strongly preferred + Experience with vision devices, medical software, or AI algorithms is desirable Strong project planning, leadership, negotiation, and presentation skills Proven ability to contribute creative yet practical solutions to problems + Strong crossorganizational collaboration with internal teams and external agencies Job: Regulatory Primary Location: United States-New York-Skaneateles Falls Other Locations: United States-New York – Home Office/Virtual, United States-Illinois – Home Office/Virtual, United States-North Carolina – Home Office/Virtual, United States, United States-Minnesota-St. Paul, United States-Minnesota – Home Office/Virtual, United States-Oregon-Portland, United States-Illinois-Chicago, IL, United States-Wisconsin – Home Office/Virtual, United States-Wisconsin-Milwaukee, United States-Illinois-Chicago – Home Office/Virtual, United States-North Carolina-Cary Schedule Full-time Travel Yes, 10 % of the Time Posting Entity Welch Allyn Req ID: