After The Badge Jobs

About the role

The Device Safety Officer (DSO) is a specialized role that ensures medical safety excellence at the intersection of pharmaceuticals and medical devices. Utilizing their medical / surgical training and deep domain expertise in device risk management, the DSO is the single point of accountability for the medical assessment of device asset risk throughout the design, development, and post-market lifecycle for assigned programs and products.

Responsibilities

• Evidence-based decision making for the severity of harms as a result of device-associated hazardous situations and associated probabilities of harm.
• Documenting, explaining, and defending device risk assessment decisions made, and updating Product Risk Management (PRM) deliverables based on new evidence and inputs from cross-functional peers and stakeholders.
• Representing Global Medical Safety at RMTs and quality event meetings convened for device assets.
• Review and sign off on device Product Risk Assessments (PRA) and other PRM deliverables requiring medical input.
• Leading standardization initiatives, including the development and maintenance of a global harms list.
• Ensuring a complete and comprehensive knowledge base of in-scope device assets and programs across the portfolio and product lifecycle.
• Ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.
• Meeting performance and risk metrics for device workflows that support strategic decision-making.
• Supporting special projects and initiatives as needed.

Qualifications

Physician / Surgeon (MD, MBBS, DO, or equivalent), with at least 3 years of postgraduate training and 2 years of clinical practice experience is required. At least 2 years of experience in the application of risk management to medical devices is required. An active medical license and board certification in a relevant discipline is strongly preferred.

Skills

• Clinical Operations
• Compliance Management
• Compliance Risk
• Consulting
• Design Mindset
• Developing Others
• Leadership
• Medicines and Device Development and Regulation
• Operational Excellence
• Quality Control (QC)
• Research Ethics
• Risk Management
• Safety Investigations
• Safety-Oriented
• Serious Adverse Event Reporting
• Standard Operating Procedure (SOP)
• Succession Planning
• Surveillance

Pay

The anticipated base pay range for this position is $199,000.00 - $343,850.00

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program.

• Vacation – 120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year