Medical Safety Manager- Image-Guided Therapy Devices

Philips

2d•$133,000 - $237,000•Remote

About The Position

The Medical Safety Manager, Image Guided Therapy Devices (IGTD) 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. This 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. It also 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. The role 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. Additionally, it conducts literature reviews and surveillance activities to identify emerging safety issues, ensuring proactive identification and mitigation of potential risks. The Medical Safety Manager provides answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust and transparency in communication regarding product safety. It contributes to the implementation of safety-related policies, procedures, and programs to promote a culture of safety and compliance within the organization. The role maintains awareness of evolving regulations and guidelines related to medical product safety and ensures compliance with applicable requirements. It also provides input into the design and conduct of safety studies and medical device vigilance activities to ensure robust safety surveillance throughout the product lifecycle. Finally, it analyzes safety data from clinical trials and post-market surveillance to identify potential safety signals and trends, facilitating early detection and intervention for improved patient safety.

Requirements

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.
Experience as a 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.
Excellent communicator, with an ability to influence cross-functional stakeholders utilizing clinical expertise and knowledge of standard of care and medical device standards.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Nice To Haves

Experience with Image Guided Therapy Devices preferred.
MD preferred.

Responsibilities

Conducting comprehensive evaluations of safety information sourced from a variety of channels such as Post-Marketing Surveillance (PMS) and literature searches.
Providing 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.
Offering 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.
Collaborating 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.
Conducting literature reviews and surveillance activities to identify emerging safety issues, ensuring proactive identification and mitigation of potential risks.
Providing answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust and transparency in communication regarding product safety.
Contributing to the implementation of safety-related policies, procedures, and programs to promote a culture of safety and compliance within the organization.
Maintaining awareness of evolving regulations and guidelines related to medical product safety and ensuring compliance with applicable requirements.
Providing input into the design and conduct of safety studies and medical device vigilance activities to ensure robust safety surveillance throughout the product lifecycle.
Analyzing safety data from clinical trials and post-market surveillance to identify potential safety signals and trends, facilitating early detection and intervention for improved patient safety.