Medical Safety Manager, Hospital Respiratory CareSleep Respiratory Care

Job Title

Job Description

Medical Safety Manager Sleep & Respiratory Care

The Medical Safety Manager independently oversees safety surveillance activities for medical products by analyzing data from post-marketing surveillance literature reviews and real-world evidence to identify risks and ensure patient well-being. The role supports regulatory compliance through the preparation of safety-related documentation including Risk-Benefit Analyses protocols Clinical Study Reports and Clinical Evaluation Reports.

Your role:

• Independently conducts comprehensive safety evaluations using data from post-marketing surveillance literature reviews and clinical trials to proactively identify and assess potential risks and safety signals.
• Provides critical safety insights and recommendations for risk management activities including Health Hazard Evaluations Risk-Benefit Analyses and recall procedures ensuring robust patient safety measures are in place.
• Supports New Product Introduction clinical studies and post-marketing efforts by delivering safety-related perspectives and collaborating on safety inputs for regulatory submissions and key documentation such as RBAs protocols Clinical Study Reports and Clinical Evaluation Reports.
• Responds to safety-related inquiries from healthcare professionals patients and internal stakeholders fostering trust through transparent communication and supporting the implementation of safety policies procedures and programs to promote a culture of compliance.
• Stays current with evolving medical product safety regulations and guidelines offering input into the design and execution of safety studies and vigilance activities to ensure adherence to requirements throughout the product lifecycle.

Youre the right fit if:

• Youve acquired 5 years of experience with a bachelors degree or 3 years experience with a masters degree or higher in areas such as Medical/Clinical Affairs/Medical Safety in the Medical Device industry strongly preferred. Prior bedside Respiratory Therapist experience is required. Experience with human factors is preferred but not 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 Bachelors/masters degree or higher in Medical Science Nursing or equivalent. MD/PhD preferred. You must be a Registered Respiratory Therapist (RRT).
• You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.
• Youre 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 companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.

This is an office-based role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters and we wont 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 Murrysville PA is $129375 to $207000.

The pay range for this position in Plymouth MN is $135844 to $217350.

The pay range for this position in Cambridge MA San Diego CA and Bothell WA is $144900 to $231840.

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. For this position you must reside in or within commuting distance to Plymouth MN.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

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