Experience

Neopharm Group

• Israel
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• RA Lead – Medical Device

  • Jul 2021 - Present

• Medical Device Regulatory Affairs Specialist

  • Dec 2015 - Present

  Medical Device Regulatory Affairs Specialist supporting the company's regulatory activities:Product regulatory due diligence assessment and submission of medical device registration files to the authority, license maintenance including post-market regulatory activities - reportable events, field safety actions, import regulations compliance.



Trupharm Marketing

• QA&RA Engineer

  • Mar 2012 - Dec 2015

  Quality System maintenance and support in compliance with the requirements of ISO 13485, ISO 9001 and GMP standards: Involved in various Quality Assurance processes - writing and updating the company's procedures and work instructions, execution of internal and suppliers audits, implementing CAPA, management of change control and quality complaints, Risk management, document control, and management review preparation. Regulatory affairs specialist supporting medical device submission to the authority: Register products, maintain existing product licenses, provide regulatory advice and support the regulatory needs. Show less