דרושים Regulatory Affairs Specialist ב-Philips ב-Israel, Haifa

You are responsible for

• Compile and maintain regulatory documentation databases or systems
• Support cross functional teams with regulatory guidance
• Coordinate efforts associated with the preparation of regulatory documents or submissions
• Coordinate, prepare, or review regulatory submissions for domestic or international projects
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation

To succeed in this role, you’ll need a customer-first attitude and the following

• Student for M.Sc. in BiomedicalEngineering/ Life Sciences, orequivalent degree
• Grades – 80+
• At least 1.5 years left before graduation
• Ability to work at least 18 hours per week (not including Friday)
• Fluent in English
• Relevant experience and familiarity with medical device industry - an advantage

Our hybrid working model is defined in 3 ways:

The

The

Your role:

• Act as the Regulatory Affairs representative for CT/AMI products, supporting regulatory activities such as labeling, marketing, technical documentation, global registrations, and regulatory design change assessments within the product Development Life Cycle.

• Provide regulatory guidance to cross-functional teams throughout all design control phases for new products and major/minor changes.

• Coordinate and prepare document packages to support global submissions and regulatory activities.

• Support regulatory audits and compliance activities.

• Serve as the local regulatory liaison between markets and the BIU site.

• Maintain Product Shipment Authorization for CT/AMI product lines, ensuring compliance with localization and licensing requirements

You're the right fit if you have:

• A relevant academic degree

• 2-3 years of experience in a regulated and technical environment

• Knowledge of global regulations for successful preparation and submission of regulatory documentation

• Strong English communication skills (written and oral)

• Team player with the ability to collaborate effectively with cross-functional teams

Indicate if this role is an office role.
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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