Medical Safety Manager - EI

Philips; United States; Remote; USD 140,000 - 237,000; Full time

Benefits offered by this job

401k match

PTO

HSA contributions

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Medical Safety Manager for Enterprise Informatics (EI) to evaluate safety information from PMS and literature, under limited supervision. The role emphasizes risk management, regulatory submissions, and safety communications across stakeholders.

You will conduct literature reviews, contribute to safety studies, and help implement safety programs to ensure compliance and robust patient protection throughout the product lifecycle.

Qualifications

• Active clinical license (Nursing or MD strongly preferred).
• 7+ years in Medical/Clinical affairs in Medical Device/Biotech industry or equivalent.
• Knowledge of standards/regulations for medical devices (ISO, IEC).
• Experience with risk management, HHE, RBA and regulatory documents.

Responsibilities

• Support patient safety by contributing insights to Risk Management, HHE, Risk-Benefit analyses, and recalls.
• Assist in safety perspectives for NPI projects, clinical studies, and PMS efforts.
• Provide safety inputs for regulatory submissions and documents (RBA, CSR, CER).
• Conduct literature reviews and surveillance to identify emerging safety issues.
• Contribute to safety policies to promote a culture of safety and compliance.
• Input into design and conduct of safety studies and vigilance activities.
• Analyze safety data to identify signals and trends for patient safety.

Skills

Medical Safety

Clinical knowledge

Regulatory compliance

Cross-functional collaboration

Decision making

Education

Bachelor’s degree in medical field

Master’s degree (preferred)

MD (preferred)

Tools

ISO/IEC standards knowledge

Job description

Job Title

Medical Safety Manager - EI

Job Description

Medical Safety Manager, Enterprise Informatics

The Enterprise Informatics Business portfolio connects clinical informatics, data management, and interoperability to deliver improved clinical insights to health care providers. The Medical Safety Manager, Enterprise Informatics (EI) 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 initiative-taking 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.

You’re the right fit if:

• You’ve acquired 7+ years of experience in areas such as Medical/Clinical affairs in Medical Device/Biotech industry or equivalent. You must have an active clinical license (Nursing or MD strongly preferred).
• Your skills include a strong knowledge 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.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

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.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.