- Lead business critical new product development projects for AI SaMD (Artificial Intelligence Software as Medical Device) and provide regulatory oversight to maintain lifecycle ensuring that the state-of-the-art requirements are maintained.
- Develop regulatory strategies and communicate risks within regulatory strategies vs project plan, and outline proposals for balancing the project risks to projects teams and RA management.
- Lead and professionally communicate and negotiate directly with regulatory enforcement entities (, governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management.
- Providing guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with EU MDR, ISO 13485 and ISO 14155, China NMPA, Canada, 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.
- 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.
- 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.
- Minimum of a Bachelor of Science degree in a Technical, Quality, Regulatory or Business discipline.
- Minimum of 7+ years' experience in FDA-regulated Medical Device/ Health-tech environments.
- First-line experience with US FDA, China NMPA and EU MDR, including strong understanding surrounding EU MDR requirements is required.
- Maintains detailed knowledge of ISO 13485 and QSR requirements.
- Experience with successful preparation and submission of Technical Documentation, 510K, De Novo, PMA, and registrations of medical devices globally is preferred.
- Experience with Software as Medical Devices (SaMD), and Imaging Devices is highly preferred.
- Team player who can work in a matrix environment with teams in different locations.
- Proficiency in English, additionally in German would be a plus.
- An attractive permanent job in a motivated team in an open and collegial atmosphere
- Versatile, challenging tasks in a growing company in an international environment
- An innovative environment with a wide range of development opportunities
- An attractive salary model, exemplary social benefits and an additional pension scheme.
- Flexible working hours, massages, sports courses, regular team events and much more.
- Numerous offers as part of our "Employer of Choice" program (including company pension schemes, family services, health program, modern working time models).
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Principal Quality and Regulatory Affairs Specialist - Taufkirchen, Deutschland - Philips
Beschreibung
Job Title
Principal Quality and Regulatory Affairs Specialist (f/m/d) Healthcare/UltrasoundJob Description
In this role, you have the opportunity to play an integral role in the development and deployment of innovative, compliant regulatory strategies and obtaining/maintaining product market access clearances within the Ultrasound Regulatory Affairs Team.
You are responsible for
To succeed in this role, you'll need a customer-first attitude and the following
In return, we offer you
As a company for health and wellbeing, the compatibility of our employees' professional and private life is an important aspect for Philips. Therefore, we offer numerous services to support you for example "Kids and more" as part of our family services, the "Philips in Balance - health program", as well as modern working time models.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status.
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