Regulatory Affairs Administrator

2 months ago

Ra'ananna, Israel Philips Full time
Job TitleRegulatory Affairs Administrator

Job Description

As Regulatory Affairs Specialist you 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


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 the lives of others.
⢠Learn more about our business.
⢠Discover our rich and exciting history.
⢠Learn more about our purpose.

If youâre interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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