In this role, you have the opportunity to
Work for a progressive and dynamic company within the medical device industry in a challenging global regulatory environment, develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submission.
You will prepare comprehensive regulatory strategies for complex new devices and post market changes. Clearly communicates strategies to RA management, project teams, and business unit leadership. Preparing regulatory filings for new products, as well as post market changes. As necessary, reviews complex regulatory issues with RA management.
You are responsible for
Lead business critical new product development projects and provide regulatory oversight to maintain lifecycle ensuring that the state of the art requirements are maintained;
Able to identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to projects teams and RA management;
Professionally negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management;
Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained;
Providing guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA’s guidance documents, and including requirements that are relevant to the overall Philips Ultrasound priorities globally;
Ensuring compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect;
Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols;
Where applicable, represent Philips in an international committee chartered to develop an applicable standard;
As needed, you will represent Philips Ultrasound Regulatory Organization in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body;
Mentor and coach Philips Ultrasound regulatory professionals in their development;
You are a part of
You are a part of Philips Ultrasound Regulatory Affairs Organization with a global footprint. You will report to Head of Regulatory Affairs for Business Group Philips Ultrasound. The Regulatory Affairs team is multicultural and are enthusiastic professionals that work as a team to ensure regulatory compliance.
To succeed in this role, you should have the following skills and experience
Bachelor/Master of Science degree in a technical or business discipline;
Minimum of 8-10 years of experience in a medical device company;
First line experience with US FDA, China NMPA and EU MDD is required;
Understands the requirements surrounding EU MDR requirements;
Maintains detailed knowledge on the subject of ISO 13485 and QSR requirements;
Experiences surrounding international regulatory submissions and registrations is required;
Must have experience with successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally;
Experience with Software as Medical Devices, and Ultrasound Imaging Devices is preferred;
Team player who can work in a matrixed environment with teams in different locations;
10-15% of travel may be required;
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 .
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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.