Senior Regulatory Specialist-Medical Device (Remote)

Hillrom

null

United States

Healthcare - Allied Health
(No Timezone Provided)

Hillrom is a $2.8B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hillrom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.

Description

Front Line Care (FLC) is a business unit of Hillrom focusing on medical devices that 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 FLC 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 respiratory care devices.

The Sr Regulatory Affairs (RA) Specialist is responsible to build and deliver on regulatory strategies and technical documentation to support regulatory submissions in US and Canada for Front Line Care medical devices. This individual will collaborate closely with other regulatory experts in these markets or other regulatory experts in other markets to achieve the best possible outcomes for effective product market clearances. This individual is responsible for a broad range of products in the Front Line Care portfolio including vision care and physical exam devices and software, artificial intelligence and software as a medical device (SaMD). The Sr RA Specialist supports new and sustaining product development teams and will work closely with cross functional team members to assist with regulatory issues related to such items as labeling, marketing claims and testing requirements. The Sr RA Specialist is an individual contributor and reports directly to the US Manager of Regulatory Affairs.

Qualifications

  • Bachelor’s degree is required. Engineering, biology, or science related field preferred.
  • Minimum 5 years’ experience in regulatory affairs. Advanced degree may be considered as partial fulfillment of experience.
  • Experience with successful preparation of 510(k)’s and/or PMAs is required
  • Proven ability to contribute creative yet practical solutions to problems
  • Strong cross-organizational collaboration with internal stakeholders and external regulatory agencies
  • Strong project planning, leadership, negotiation, and presentation skills
  • Experience with SAP strongly preferred
  • Senior Regulatory Specialist-Medical Device (Remote)

    Hillrom

    null

    United States

    Healthcare - Allied Health

    (No Timezone Provided)

    Hillrom is a $2.8B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hillrom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.

    Description

    Front Line Care (FLC) is a business unit of Hillrom focusing on medical devices that 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 FLC 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 respiratory care devices.

    The Sr Regulatory Affairs (RA) Specialist is responsible to build and deliver on regulatory strategies and technical documentation to support regulatory submissions in US and Canada for Front Line Care medical devices. This individual will collaborate closely with other regulatory experts in these markets or other regulatory experts in other markets to achieve the best possible outcomes for effective product market clearances. This individual is responsible for a broad range of products in the Front Line Care portfolio including vision care and physical exam devices and software, artificial intelligence and software as a medical device (SaMD). The Sr RA Specialist supports new and sustaining product development teams and will work closely with cross functional team members to assist with regulatory issues related to such items as labeling, marketing claims and testing requirements. The Sr RA Specialist is an individual contributor and reports directly to the US Manager of Regulatory Affairs.

    Qualifications

  • Bachelor’s degree is required. Engineering, biology, or science related field preferred.
  • Minimum 5 years’ experience in regulatory affairs. Advanced degree may be considered as partial fulfillment of experience.
  • Experience with successful preparation of 510(k)’s and/or PMAs is required
  • Proven ability to contribute creative yet practical solutions to problems
  • Strong cross-organizational collaboration with internal stakeholders and external regulatory agencies
  • Strong project planning, leadership, negotiation, and presentation skills
  • Experience with SAP strongly preferred