Philips Global Post Market Surveillance Clinical Expert in United States of America - Home Based, Massachusetts
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 request. You may contact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
Help transform Post Market Surveillance (PMS), which will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.
This role will have significant visibility and a chance make a real difference to our employees and our customers as we add value through post market insights. You will use your clinical experience and expertise to assess events describing significant injury and death allegations at Philips to ensure causal relationship based medical judgement is used to inform business decisions. Additionally your medical expertise will be used to develop processes and contribute to activities such as adverse event reporting, Issue Impact Assessments (IIAs), responses to regulatory inquiries, and Risk Management, ensuring timely assessment and escalation of issues with the potential for patient harm.
Your responsibilities include:
Accountable for preliminary clinical assessments for issues alleging significant injury or death for Philips product as well as providing input for Issue Impact Assessments (IIA).
Participate in Executive Correction and Removals Governance Board meetings and provide clinical insights to support consistent decision making across Philips.
Implement and improve the standard way of operating for Philips PMS clinical input to ensure that respective processes are timely, effective and efficient.
Drive compliance to global regulations and standards, ensuring operation activities are in accordance to requirements of external governing authorities, internal Quality Management System (QMS), and Philips business process methodologies.
Collaborate with businesses, markets, functions, and suppliers to communicate PMS clinical insights in support for driving continuous improvement initiatives for complaint handling and corrections and removals for Philips products.
Partner with global complaint handling and corrections and removals teams to support improvements in Philips and business level processes to enable efficient and effective execution.
Being part of the PMS Operations team, continuously evaluate effectiveness of overall post market processes to resolve gaps or areas for improvement and solutions to mitigate.
Responsible for contributing to team, department and/or business results, including recruiting, developing and coaching of talent. Typically influences work of cross-functional or extended business partners.
You are a part of
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interactions with Philips Business Group and the leadership. 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.
Through timely, effective and efficient post market clinical input, you will ensure that the voice of the customer is collected and understood.
To succeed in this role, you should have the following skills and experience
Strong analytical, conceptual and creative thinking skills. A problem solving and pragmatic attitude.
Licensed or certified healthcare professional with patient care experience.
Bachelor’s degree or higher in science with a preference towards healthcare or medical profession (e.g. nurse, nurse practitioner, physician assistant).
Direct involvement in activities such as Health Hazard Evaluation, corrections and removals, complaint handling, adverse event reporting, regulatory inquiry responses, and/or risk management documentation is required.
Experience with FDA and/or other regulatory audits/inspections is required.
Must have knowledge of regulations relative to corrections and removals, complaint handling and reporting, and risk management such as: ISO 9001/13485/14971, FDA Regulations (21CFR (803, 806, 820)), CMDR, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), and EU MDR.
Must possess strong customer focus with doing it right the first-time approach and be able to demonstrate high performance behavior of shared accountability.
Ability to drive decision-making while effectively communicating detailed information and strategic decisions to project team members of all levels.
Post Market experience preferred.
Proven experience driving key initiatives or processes in a global, matrixed organization. Experience with leading organizational change preferred.
Process excellence or green belt six sigma is preferred.
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 competitive 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.
Why should you join Philips?
Working at Philips is more than a job. It’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 continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn 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 blog. Once 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 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.
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