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RA Device Sr. Manager

Regulatory Affairs
Rehovot, Israel

We are looking for a RA Device Sr. Manager to be responsible for the hands on regulatory activities associated with bringing a new medical device combination product to the US market. Projects are complex, therefore responsibilities may include developing regulatory strategy recommendations for a product category or therapeutic area.

Job description

  • Manage regulatory activities that support the development of new commercialized products in the US & EU, and maintenance of existing ones.


  • Serve as the Regulatory point of contact on project teams for the development of regulatory strategies, milestones, and submission deliverables for the development of new products.


  • Be responsible for developing compliant labeling & product registrations.


  • Prepare regulatory plans and assessments per newest updates.


  • Author Standard Operating Procedures (SOP) and Standardized Work Instructions (SWI) for the 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 investigations of quality, product safety and/or regulatory issues arising from partners, customers, the field, vendors, and regulatory authorities. Support implementation of corrective actions and procedure improvements for issue resolution.


  • Background in medical device development


  • Experience with FDA and MDR submissions


  • Advanced analytical skills, communication & writing skills, and critical thinking skills – a must


  • Ability to identify and apply policies and general regulations to specific products and projects – a must


  • 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


  • Engineering degree in a health sciences field such as biochemistry, chemistry, pharmacy, pharmacology, or nutrition & food sciences combined. Advanced degree preferred.


  • 8+ years of experience in the health care or pharmaceutical industry


  • 8+ years of hands on experience in regulatory affairs

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