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RA Device Sr. manager

תיאור

A medical device start up in Rehovot (next to a train station) is looking for a   RA Device Sr. . manager. - Hibrid position
ctivities associated with bringing new medical device combination product to the US market. Projects are with significant complexity and may include developing recommendations on regulatory strategy for a product category or therapeutic area.
Major duties and responsibilities:

Manage regulatory activities that support the development of new and maintenance of existing commercialized products in US & EU.
Serve as Regulatory point of contact on project teams to develop regulatory strategies, milestones and submission deliverables for the development of new products.
Responsible for developing compliant labeling & product registrations
Preparation of regulatory plans and assessment per newest updates
Author Standard Operating Procedures (SOP) and Work Instructions (SWI) for Regulatory Affairs department, as needed. Includes the biannual review, and revisions, to existing SOPs and SWIs.
Monitor and interpret the impact of ongoing development in the regulatory environment and work with internal and external stakeholders on impact of new laws and regulations.
Support investigation of quality, product safety and / or regulatory issues arising from partners, customers, field, vendors and regulatory authorities. Support implementation of corrective actions and procedure improvements to resolve issues.

דרישות התפקיד

Background in medical device development
Experience with FDA and MDR submissions
Must possess advanced analytical skills, communication/writing, and critical thinking and the ability to identify and apply policies and general regulations to specific products and projects
Ability to monitor, analyze, raise awareness and assess impact of regulatory issues for stakeholders inside and outside of Regulatory Affairs
Ability to effectively lead project teams
Ability to work in a multi-disciplinary team
Proactive and self-motivated with a collaborative attitude and a desire to continuously learn.
Education and Knowledge Requirements:

Engineering degree in a health sciences field such as biochemistry, chemistry, pharmacy, pharmacology, or nutrition or food sciences combined
8+ years of experience in the health care or pharmaceutical industry and 8+ years of hands on experience in regulatory affairs.
Advanced degree preferred.


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