Job title
Medical safety manager
Job description
If you are a colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon requestYou may c ontact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
The medical safety manager (msm) is responsible for end-to-end safety deliverables within a business categoryYou will ensure that clinical safety assessments are key inputs into the product development, quality and regulatory processesAs the safety lead, you will ensure that our products and solutions that not only meet regulatory safety standards, but deliver best-in-class patient careA medically independent voice is key; however, collaboration in ensuring clinical safety is expected.
You are responsible for:
Clinical expertise on the use of the medical device and its effects on the patient/user.
Medical safety input into the risk management processAssess clinical risks and hazards associated with use of the medical deviceUse evidence-based practice and literature searches to determine potential harms, severity of harms, and likelihood of harms to developWork with the risk management team to develop and maintain the safety risk assessment.
Assessment of risks related to products/devices in field as a member of the health hazard evaluation (hhe) teamProvide clinical safety input into hhes and provide drafts of the hhe to the medical director of the connected care cluster for review/approval.
Medical safety review and input into post-market deliverables such as clinical evaluation reports, post-market surveillance reports, periodic safety update reports, and post-market clinical follow-up reports.
Awareness of safety related deliverables across the business, including risk analysis, capa, hhes, field actions, post-market surveillance activities, and complaints.
Development of clear and strong relationships between r&d, quality, regulatory, and other stakeholders to allow for a robust risk management system and assurance of clinical safety.
Medical safety perspective into new product development and the design change processThis includes medical safety input for end-to-end product lifecycle support, regulatory and clinical compliance assessments, and competitor assessments.
Clinical safety, usability & compliance input into human factors – formative and summative.
Knowledge of worldwide clinical practice guidelines, safety requirements, procedures, and expectations of global competent authorities.
Clinical input into key development activities with a focus on patient safety requirements and clinical requirements.
Proactive regulatory and clinical compliance assessments/ competitor assessments.
Periodic maude reviews and assessments.
You are a part of:
As a result of philips renewed dedication to quality, it has recently restructured its organization to ensure you and your department have clear collaboration with philips business group and market leadership, and can harness the expertise of five centers of excellence (coes)These 5 coes specialize in the following capabilities: regulatory & clinical affairs, supplier quality, quality management system, quality assurance & engineering, and compliance & auditAs part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience:
Licensed healthcare provider required with a current active license
3+ years of experience in clinical safety roles within industry strongly preferred
Experience in the scientific method, medical/clinical writing and clinical assessments
Excellent interpersonal and problem solving skills
Understanding and interest in global regulations
Passion for clinical safety and innovation
In return, we offer you
We believe that every growth period creates an exceptional career runwayIn fact, the clinical and scientific affairs leadership team gets out of bed every morning with the sole focus of growing the business and growing the people who contribute to itLuckily, you are the benefactor of this unique opportunity and leadership commitment- likely to experience an exciting high stakes, mobility-focused environment from which to create your own future – personally, professionally & financially.
Why should you join philips?
Working at philips is more than a jobIt’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuumOur people experience a variety of unexpected moments when their lives and careers come together in meaningful waysLearn more by watching this video.
To find out more about what it’s like working for philips at a personal level, visit the working at philips page on our career website, where you can read stories from our employee blogOnce there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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 workforceIn 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
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