Medical Safety Lead, Hospital Respiratory Care at Philips
Medical Safety Lead, Hospital Respiratory Care
- United States of America – Home Based
- Full Time
In this role, you have the opportunity to
The medical affairs safety lead will be responsible for end-to-end clinical safety within a business category. They will be responsible for ensuring clinical safety assessments as a key input into the quality and regulatory processes. As the safety lead, you will ensure that not only our products and solutions meet regulatory safety standards but help differentiate Philips products and solutions are best in class. A medically independent voice is key, however, collaboration in assessing potential safety signals is expected. This position will support our Hospital Respiratory Care team (HRC).
You are responsible for:
- Proactive clinical safety input for end-to-end product lifecycle support, regulatory and clinical compliance assessments, and competitor assessments
- Knowledgeable in risk management and serves as a subject matter expert in the therapeutic area and patient risk management throughout the product lifecycle, from new product development, to launch and commercial life
- Clinical safety input, review and approval of human factors formative and summative usability plans and reports
- Assess clinical risks and hazards associated with use of the medical device following evidence-based practices and use models for initial SRA development and SRA updates. Accountability for ensuring SRA’s are comprehensive and incorporate internal and external input to ensure accuracy on risk determination and probability of occurrence.
- Assess clinical risks and hazards associated with use of the medical device during CA HHE’s and Clinical Evaluation Reports.
- Submission of HHE drafts to medical safety officer for the connected care cluster. Member of the HHE committee.
- Provide clinical input as needed for complaints and MDR’s within the BC they support
- Build clear and strong relationships between R&D; Quality, Regulatory, and other stakeholders to allow for proactive and flexible risk management system
- Monitor external sources/trends and identify and escalate emerging issues. These include (but are not limited to), complaint & MDR/MDV trends, regulatory & market trends/intelligence, literature and scientific publications Review
- Stay informed and engaged with worldwide clinical practice guidelines, safety requirements, procedures and expectations by global competent authorities
- Prior knowledge of MAUDE reviews and assessments is ideal
- Completion of the clinical safety strategy and plan for the business category as part of the SPOR process
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 & Audit. As 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
- Bachelor’s Degree in nursing or health sciences. Advanced degree preferred
- 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
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer bold health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.
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