Regulatory Affairs Specialist

Posted Oct 21, 2019
Project ID: PHILJP00020776
Eindhoven , Noord Brabant
1 year (Nov 1, 2019 - Oct 30, 2020)
40 hrs/week
Payrate range
0 - 91 €/hr
Regulatory Affairs Specialist
o   To instruct, coach and facilitate project teams on the application of Regulatory Affairs. The application of legislation, standards and guidelines relevant for product development and manufacturing.
o   To engage with PInS sales as well as PInS customers related to the identification of relevant regulatory and compliance boundary conditions for the PInS assignment during the definition phase.
o   To provide guidance and coaching to PInS development teams in order to work in line with applicable Quality Management Systems (QMS). This can be QMS of Royal Philips or PInS, or the QMS of the customers.
o   To identify risks of non-compliance in an early stage of the project and escalate these appropriately.
o   To define, evaluate and get approval of the Project Quality Plans including Risk-Safety-Hazard analysis.
o   Assists with establishing a structure and control measures for the project related documentation, the creation of relevant records and configuration management, (DHF, DMR, DHR and TPD documentation).
o   Assisting the Project Leader in creating and maintaining the Product Risk Management and the Verification & Validation plans.
o   Creating, maintaining and reviewing (project and/or production) of Quality documentation, such as Quality & Regulatory documents, reports, procedures, work instructions, in line with the request of the customer and the applicable QMS.
o   Assists with the preparation and approval of milestone review meetings by collecting the status of all deliverables relevant for Quality and Regulatory aspects.
o   Assists with the preparation and review of relevant documentation for regulatory submission like 510K.
o   To join and support the PInS Community of Practice (CoP) on Medical Compliance.
o   Give training on Quality and Regulatory matters to PInS employees, Customers or relevant Suppliers on PInS projects.
o   To identify, initiate, execute and/or follow up actions to further build the Regulatory and Compliance competence within PInS.
o   To prepare, conduct and/or support internal as well as external (supplier) Quality Audits.
o   To prepare and support PInS and her project teams in Quality Audits.
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