Product Safety Manager
Job Title Medical Safety Manager, Enterprise Informatics Job Description Medical Safety Manager (Cambridge preferred, or other U.
S.
Hub based location) The Medical Safety Manager for our Enterprise Informatics business is accountable for patient-centric end to end medical safety inputs and oversight for pre, and post approval products and Philips supported clinical studies and risk assessments.
Your role:
Responsible for end-to-end clinical safety within the Enterprise Informatics (EI) business.
You will ensure that clinical safety assessments are key inputs into the product development, quality, and regulatory processes.
As the safety lead, you will help Philips provide customers with products and solutions that not only meet regulatory safety standards, but also deliver best-in-class patient care.
A medically independent voice is key; however, collaboration in ensuring clinical safety is expected.
Providing objective medical safety and clinical input for the valuation of potential safety issues for products in the field (IIA/HHE).
Represent Medical Affairs Safety in Correction and Removal Board meetings.
Providing objective medical safety and clinical input to product Safety Risk Assessment (SRA) or Risk Management Matrix (RMM) documents including severity, probability, and use case scenarios.
Providing Medical Safety review and input into post-market deliverables such as Post-Market Surveillance Reports, Periodic Safety Update Reports, and Post-Market Clinical Follow-Up Reports.
Proactively collaborate with cross-functional teams to provide medical safety and clinical input for end-to-end product lifecycle development, including change request disposition, verification and validation, customer inquiries, regulatory and clinical compliance assessments, and competitor assessments.
You're the right fit if:
You've acquired 3
years of clinical experience in a hospital environment preferred; 2
years of experience in clinical safety roles within the medical device industry required.
Experience with literature searches and evidence-based practice.
Software or SaMD experience is a plus but not required.
Risk Assessment experience is a plus as well.
Your skills include high-level writing skills and acute attention to detail.
Excellent interpersonal and problem-solving skills; passion for clinical safety, quality, and innovation.
Strong understanding of post-market surveillance regulations (21 CFR, MDD93/42/EEC and other applicable global regulations, ISO 14971 (Risk Management)).
You have an appropriate clinical training background such as MD, DDS, DO, PA, RN, APRN, medical informatics, etc.
and an active clinical license (preferred).
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
The ideal candidate will be in or around Cambridge, MA area however we will consider qualified candidates located near other posted hub locations.
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.
Read more about our employee benefits.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.
You may still be the right candidate for this or other opportunities at Philips.
Learn more about our commitment to diversity and inclusion here.
Philips Transparency Details The pay range for this position is $116,200 to $223,104, annually.
The actual base pay offered may vary 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 posted hub locations #LI-PH1 Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Recommended Skills Assessments Attention To Detail Certified Nurse Practitioner Clinical Works Evidence Based Practice Health Care Estimated Salary: $20 to $28 per hour based on qualifications.
S.
Hub based location) The Medical Safety Manager for our Enterprise Informatics business is accountable for patient-centric end to end medical safety inputs and oversight for pre, and post approval products and Philips supported clinical studies and risk assessments.
Your role:
Responsible for end-to-end clinical safety within the Enterprise Informatics (EI) business.
You will ensure that clinical safety assessments are key inputs into the product development, quality, and regulatory processes.
As the safety lead, you will help Philips provide customers with products and solutions that not only meet regulatory safety standards, but also deliver best-in-class patient care.
A medically independent voice is key; however, collaboration in ensuring clinical safety is expected.
Providing objective medical safety and clinical input for the valuation of potential safety issues for products in the field (IIA/HHE).
Represent Medical Affairs Safety in Correction and Removal Board meetings.
Providing objective medical safety and clinical input to product Safety Risk Assessment (SRA) or Risk Management Matrix (RMM) documents including severity, probability, and use case scenarios.
Providing Medical Safety review and input into post-market deliverables such as Post-Market Surveillance Reports, Periodic Safety Update Reports, and Post-Market Clinical Follow-Up Reports.
Proactively collaborate with cross-functional teams to provide medical safety and clinical input for end-to-end product lifecycle development, including change request disposition, verification and validation, customer inquiries, regulatory and clinical compliance assessments, and competitor assessments.
You're the right fit if:
You've acquired 3
years of clinical experience in a hospital environment preferred; 2
years of experience in clinical safety roles within the medical device industry required.
Experience with literature searches and evidence-based practice.
Software or SaMD experience is a plus but not required.
Risk Assessment experience is a plus as well.
Your skills include high-level writing skills and acute attention to detail.
Excellent interpersonal and problem-solving skills; passion for clinical safety, quality, and innovation.
Strong understanding of post-market surveillance regulations (21 CFR, MDD93/42/EEC and other applicable global regulations, ISO 14971 (Risk Management)).
You have an appropriate clinical training background such as MD, DDS, DO, PA, RN, APRN, medical informatics, etc.
and an active clinical license (preferred).
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
The ideal candidate will be in or around Cambridge, MA area however we will consider qualified candidates located near other posted hub locations.
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.
Read more about our employee benefits.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.
You may still be the right candidate for this or other opportunities at Philips.
Learn more about our commitment to diversity and inclusion here.
Philips Transparency Details The pay range for this position is $116,200 to $223,104, annually.
The actual base pay offered may vary 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 posted hub locations #LI-PH1 Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Recommended Skills Assessments Attention To Detail Certified Nurse Practitioner Clinical Works Evidence Based Practice Health Care Estimated Salary: $20 to $28 per hour based on qualifications.
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