Minnnesota Bioscience Jobs

Job Information

Hill-Rom Lead Regulatory Engineer - Medical Devices in St. Paul, Minnesota

Description

Position Summary:

The Regulatory Affairs (RA) Lead Engineer is responsible for the regulatory strategy for the Front Line Care portfolio including vision care and physical exam devices which includes software and SaMD. This position supports new and sustaining product development teams.

The Lead RA Engineer 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 RA colleagues and OUS/CA registration peers is essential.

Directly responsible for US and Canadian licensing.

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 pre-subs, IDE’s and pre-market 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 business

Qualifications

  • Bachelor's degree - preferably in Engineering or a related Science

  • Masters RA/QA is strongly preferred

  • Minimum 5 years’ experience in RA and/or product development in medical devices

  • Experience with FDA submissions strongly preferred

  • 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 cross-organizational collaboration with internal teams and external agencies

Job: Regulatory

Primary Location: United States-New York-Skaneateles Falls

Other Locations: United States-Oregon-Portland, United States-Illinois-Chicago, IL, United States-Minnesota-St. Paul, United States-Wisconsin-Milwaukee, United States-Illinois-Chicago - Home Office/Virtual

Schedule Full-time

Travel Yes, 10 % of the Time

Posting Entity Welch Allyn

Req ID: 20124013

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