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Medical Safety Manager- Sleep & Respiratory Care (Pittsburgh preferred or US hub based, hybrid)
The Medical Safety Manager for our Sleep & Respiratory Care business will be primarily involved in issue impact assessments (IIA), health hazard evaluations (HHE), and updating and improving existing medical documentation. 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.
Your role:
Responsible for end-to-end clinical safety within the Sleep & Respiratory Care business. You will ensure that medical safety assessments are key inputs into the product development, quality, and regulatory processes.
Providing objective medical safety and clinical input for the evaluation 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, Period 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 and/or home care environment including ventilators/CPAP devices, and care of patients who require mechanical ventilation (invasive ventilation, non-invasive ventilation, high-flow oxygen therapy). You must be a licensed healthcare provider with a current active license. 2+ years’ experience in medical safety roles within medical device industry strongly preferred.
Your skills include experience with literature searches and evidence-based practice, high level writing skills and acute attention to detail. You have excellent interpersonal and problem-solving skills; passion for medical safety, quality, and innovation. You have a strong understanding of post market surveillance regulations (21 CFR, MDD93/42/EEC and other applicable global regulations), and ISO 14971.
You are a Registered Respiratory Therapist (RRT) required; with advanced respiratory credentials preferred (eg. NPS, CPFT, ACCS).
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) position.
Minimal travel required (<10%).
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 (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Read more about our employee benefits (https://www.careers.philips.com/na/en/best-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 (https://www.careers.philips.com/global/en/diversity-and-inclusion) .
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 (https://www.careers.philips.com/na/en/best-employee-benefits) .
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 location .
#LI-PH1
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 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, option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran