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 work very closely with various cross-functional leaders within the business and the markets, and help outline regulatory submission strategy, priority and execution plan to support various new and sustaining product registrations in all key markets. You will also be responsible for providing needed direct support to business critical New Product Introduction projects and maintaining lifecycle of regulatory processes that are relevant to meet state of the art requirements.
You are responsible for
Interface with business marketing product managers and marketing experts from key markets, to align on global submission priority and desired approval timeline;
Engage in strategic dialogue with various key markets regulatory organization and provide an outline of product submission strategy to the business regulatory organization supporting new and sustaining product development;
Work closely with the regulatory operations team, and the regulatory product subject matter experts, and execute on established priorities to achieve regulatory approvals within the desired approval timeline;
Outline and enable real-time maintenance of relevant data to clearly communicate global product current registrations, priorities, and critical timelines;
With the changing, evolving key market regulatory requirements, take the lead in identifying opportunities and work closely with the various cross-functional team, such as R&D, Regulatory Affairs, Marketing etc. to align on expectations;
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;
Reviewing and recommending changes for design control processes and manufacturing procedures to maintain quality and regulatory compliance;
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 updating the procedures when new regulatory requirements are determined to go into effect;
Advising on regulatory policy (for market release) in line with Philips regulatory policy;
Where applicable, represent Philips in an international committee chartered to develop an applicable standard;
Representing 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;
Manage, 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 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;
Experiences surrounding international regulatory submissions and registrations is required;
Understands the requirements surrounding EU MDR requirements;
Maintains detailed knowledge on the subject of ISO 13485 and QSR requirements;
Must have experience with successful preparation and submission of Technical Documentation, 510(k), 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% 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.