Medical Safety Manager- Image-Guided Therapy Devices

Philips International; Northern (KY); Hybrid; USD 133,000 - 212,000; Full time

Job summary

Philips is seeking a Medical Safety Manager in Image Guided Therapy Devices to lead safety evaluations, assess risks, and support PMS and literature surveillance.

You will collaborate with regulatory and clinical teams to prepare RBAs, CSR, CERs, and contribute to NPI projects while ensuring compliance with ISO/IEC standards.

Qualifications

• Bachelor’s or Master’s in Medical, Nursing, or equivalent; MD preferred.
• 5+ years in Medical Device/Biotech clinical affairs or equivalent.
• Image Guided Therapy Devices experience preferred.
• Strong knowledge of ISO/IEC medical device standards.
• Ability to conduct safety studies and risk assessments.
• Clinician background required.

Responsibilities

• Evaluate safety information from PMS and literature.
• Contribute to risk management, HHEs, and risk-benefit analyses.
• Support regulatory submissions with safety inputs.
• Perform literature reviews to identify safety signals.
• Assist in safety-related policies and training.
• Collaborate across teams for product safety throughout lifecycle.

Skills

Medical safety

Regulatory submissions

PMS surveillance

Clinical affairs

Risk management

Stakeholder comms

Education

Bachelor/Master in Medical field

Job description

Job Title

Medical Safety Manager- Image-Guided Therapy Devices

Job Description

Medical Safety Manager, IGT-D The Medical Safety Manager, Image Guided Therapy Devices (IGTD) is responsible for conducting comprehensive evaluations of safety information sourced form 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 improves patient safety.

You're the right fit if:

• You’ve acquired 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 with Image Guided Therapy Devices preferred.
• Experience as a clinician is required.
• Your skills include a strong of relevant standards and regulations for the medical device industry (ISO, IEC, etc.).
• You have 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.
• You have a Bachelor’s/Master’s Degree in Medical, Nursing, or equivalent.
• MD preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent communicator, with an ability to influence cross-functional stakeholders utilizing your clinical expertise and knowledge of standard of care and medical device standards.

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.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in 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 is $133,000 to $212,000. The pay range for this position in AK, DE, HI, MD, MN, and RI is $140,000 to $223,000. The pay range for this position in CA, CT, DC, MA, NJ, NY, or WA is $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. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

Additional Information

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. Company relocation benefits will not be provided for this position. This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace. At Philips, we believe that every human matters. As a global health‑tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people’s lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888‑367‑7223, option5, for assistance.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace. Know Your Rights