Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist page is loaded## Principal Regulatory Affairs Specialist locations:
Bothell, Washington, United States:
Cambridge (US), Massachusetts, United States:
Washington, District of Columbia, United States:
Plymouth, Minnesota, United Statestime type:
Full time posted on:
Posted Todayjob requisition :
573784### Job Title Principal Regulatory Affairs Specialist###

Job Description As a critical member of the Philips Ultrasound
- Regulatory Affairs Organization, the Principal Regulatory Affairs Specialist will lead and provide regulatory oversight for critical new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA, and other governmental agency/notified body Regulatory Compliance standards/requirements.
** Your Role:
*** Leads business critical new product development projects and provide regulatory oversight to maintain lifecycle ensuring that requirements are maintained. Identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to projects teams and RA management. Mentor and coach Philips Ultrasound regulatory professionals in their development.
* Will 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 regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.
* Providing guidance on current, new and updated Regulatory compliance procedures globally, 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.
* 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. May represent Philips in an international committee chartered to develop an applicable standard.
** You're the right fit if:
*** You have a minimum of 8+ years’ Regulatory Affairs experience within FDA regulated Medical Device/Health Tech product environments.

Experience with Software as Medical Device (SaMD) and Ultrasound Imaging Devices highly desired.
* You have strong knowledge of US FDA, China NMPA, CE Marking, EU MDD/MDR, JPAL, Canadian CMDCAS etc. with proven/successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally.
* You’re able to work in a large, matrixed organization and collaborate with globally dispersed partners/team members.
* You have a minimum of a Bachelor’s Degree in Regulatory Affairs, Engineering, Life Sciences or comparable disciplines (Required). Master’s degree, RAC Certification desired.
* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this **.
**** How we work together:
** We believe that we are better together than a part. For our
*** Office-based
*** teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
** This is an Office role.
**** About Philips:
** We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.
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