Philips Regulatory Affairs Administrator 

Israel 

101096861

Regulatory Affairs AdministratorJob Description

Asyou will support product regulatory plans and product registrations, participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements and standards
Your role:

• Supporting regulatory planning for new product introductions and product changes, and assist in maintaining, regulatory compliance.

• Product submissions, global registrations and communication with authorities

• Managing compliance to global regulations, standards and guidelines Guide R&D, clinical and marketing teams regarding regulatory related considerations

• Regulatory support for internal audits, external audits and inspections.

• Recommends changes for labelling to ensure regulatory compliance.

• Monitors and improves tracking/control systems.

• Keeps abreast of regulatory procedures and changes.

• Represent Regulatory Affairs as team member of product development projects.

• Monitor and provide information pertaining to impact of changes in the regulatory environment

• Review regulatory procedures and update as necessary.

• Review SW release documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments

You're the right fit if you have:

• Academic degree in computer science, biological sciences, engineering or equivalent

• Experience in regulatory roles

• Fluent English

• Good analytical skills and writing skills

• Good understanding of the Quality System Regulation (ISO 13485, MDR, 21 CFR Parts 803, 806 and 820) is a plus

• Ability to interact and communicate in English, including demonstrable writing, speaking, and comprehension skills; ability to communicate across levels of the organization

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 the lives of others.
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