RA Associate | Israel

Job Title: RA Associate

Location: Caesarea, Israel

Department: QA/RA

Reports to: RA manager

Job Description: Supporting pre & post market regulatory activities (global regulatory submissions and assessments, reportable events)

Key Responsibilities & Authorities:

  • Regulatory assessments and registrations.
    Review promotional material and labeling for regulatory compliance.
    Write, update and maintain technical files for Class I and Class IIa.
    Support global regulatory requirements and submissions.
    Regulatory assessment of changes.
  • Reportable events.
    Assessment of potentially reportable events worldwide, when necessary - report reportable events (worldwide).
    Keep track of global MDRs of different companies and identify the ones which require assessment.

Experience Requirements:

  • Advantage: applicable experience, working in medical device companies, knowledge of medical device regulations and standards, especially US (FDA) and EU (MDD/MDR) related

Education:

B.S. Degree, in a related scientific or engineering discipline.

Job Specific Skills (Languages, SW, systems, etc.'):

Excellent verbal and written communication skills (Hebrew and English).
Office proficient, experience and understanding of ERP, PLM, LMS, Doc Control systems.

Other Requirements for the role (% of travel, etc.):

  • Ability to work in a team minded approach to achieve individual and company success.
  • Able to confidently deal with ambiguous issues and provide input towards suitable actions, work independently, utilizing research and problem solving skills.
  • Interpersonal and presentation skills.

Working Relationships: 
Internal:  All departments
External: Global distributors and other as required

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The website was last updated : 14 Jan 2019

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