Medical Safety Manager, Hospital Patient Monitoring

About the role

The Medical Safety Manager, Hospital Patient Monitoring is responsible for conducting comprehensive evaluations of safety information sourced from a variety of channels such as Post-Marketing Surveillance (PMS) and literature searches, working under limited supervision.

Your Role

• Provides essential support in bolstering patient safety by actively contributing insights and recommendations to critical processes such as Risk Management, Health Hazard Evaluations (HHE), Risk-Benefit analyses, and recall procedures.
• Offers valuable assistance in delivering safety-related perspectives for New Product Introduction (NPI) projects, clinical studies, and Post-Marketing Surveillance (PMS) efforts, facilitating informed decision-making.
• Collaborates effectively to furnish pertinent safety inputs for regulatory submissions and key documents such as Risk-Benefit Analyses (RBA), protocols, Clinical Study Reports (CSR), and Clinical Evaluation Reports (CERs), ensuring compliance and transparency in safety evaluations.
• Conducts literature reviews and surveillance activities to identify emerging safety issues, ensuring proactive identification and mitigation of potential risks.
• Provides answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust and transparency in communication regarding product safety.
• Contributes to the implementation of safety-related policies, procedures, and programs to promote a culture of safety and compliance within the organization.
• Maintains awareness of evolving regulations and guidelines related to medical product safety and ensures compliance with applicable requirements.
• Provides input into the design and conduct of safety studies and medical device vigilance activities to ensure robust safety surveillance throughout the product lifecycle.
• Analyzes safety data from clinical trials and post-market surveillance to identify potential safety signals and trends, facilitating early detection and intervention for improving patient safety.

Qualifications

• 5+ years of experience with Bachelor's OR minimum 3+ years of experience with Master's in areas such as Medical/Clinical affairs in Medical Device/Biotech industry or equivalent.
• Critical Care, and/or Telemetry experience required.
• Experience as a practicing clinician is required.
• Strong knowledge of relevant standards and regulations for the medical device industry (ISO, IEC, etc.).
• Strong knowledge and understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses and how to conduct them in a medical device environment.
• Bachelor's/Master's degree in Medical, Nursing, or equivalent. MD preferred.
• Excellent communication skills, with an ability to influence cross-functional stakeholders utilizing clinical expertise and knowledge of standard of care and medical device standards.
• Must be willing and able to travel up to 25% based on business needs.

How We Work Together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is a field-based role. EDT and CDT time zone preferred.

Pay

• AL, AZ, AR, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MI, MS, MO, MN, NC, ND, NE, NH, NM, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WI, WV, or WY: $133,000 to $212,000
• AK, DE, HI, MD, MN, and RI: $140,000 to $223,000
• CA, CT, DC, MA, NJ, NY, or WA: $149,000 to $237,000

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.

Benefits

• Generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• Stock purchase plan
• Education reimbursement