Adely Levy, M.Sc

Quality & Regulatory Project Manager

Adely levy holds M.Sc in Plastics and polymers Engineer Master's degrees Research Program .

Adely has over 15 years experienced in the Medical Device Industry at small and large companies. RA/QA Manager and Program Manager.

Oversee platform development, POC (Proof of Concept), lead optimization, validation, tech transfer and manufacturing.

Extensive knowledge and experience of product development, RA/QA management, strategies in biotechnology products design development, and execution of preclinical studies.

 

Skilled in Supplier Qualification, FDA CFR 820, FDA Audits, 510K Submissions ISO 13485 QMS. CE Renewal, CE audits, Technical Files.

Proactive, collaborative, self-motivated, self-learning, team player.

Ability to prioritize, multi-task and perform in a deadline-oriented environment.

Excellent problem solving and risk-based decision-making skills.

Strong project management and time management skills.

Ability to work closely with multiple internal, external, and cross functional teams.

Creativity is a natural extension of our enthusiasm
Earl Nightingale
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