טוען

משרה מספר 378945

Professional Regulatory Affairs for Medical Device...

זכרון יעקב
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היקף משרה
  • מלאה
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01/09/2021

תיאור המשרה

An established and fast-growing consulting firm serving the Medical Device & Digital Health industries is looking to hire a professional to provide Regulatory Affairs consulting. To meet our clients’ expectations through the development, implementation, and delivery of their products you may perform part or all the following:• Define regulatory strategies and pathways.• Create Technical File/Documentation.• Prepare FDA submission such as EUA, Breakthrough, 510K etc.• Submit global registrations worldwide: coordination and preparation of document packages for regulatory submissions.• Support design and development of products from a regulatory perspective.• Advise on standards, labelling and UDI requirements.

דרישות התפקיד

Desired experience and skills• 3+ years’ related experience in the medical device industry.• Experienced in submission package preparation such as 510K, EUA, Pre-_sub, Breakthrough, Technical File for the EU, APAC submissions etc. • Bachelor's degree or higher in life science-related discipline, engineering, or law• Excellent English proficiency