Assistant Compliance Manager

Igentify

Haifa, IL
  • Job Type: Part-Time
  • Function: Regulatory Affairs
  • Post Date: 02/05/2021
  • Website: igentify.com
  • Company Address: Nahum Het 5 Tirat HacCarmel, Haifa, 3508504

About Igentify

Igentify, founded in 2016, is a privately held company that strives to import genomic molecular results directly from sophisticated laboratory testing equipment and analyze it using a state of the art genomic database and algorithms.

Job Description

The Assistant Compliance Manager will assist the Compliance Manager (Quality, Regulation and Information Security Manager) with complaince missions and activities and be responsible for:

  • Delivering training related to Quality Management System / Information Security Management System
  • Processing of complaints and non-conformities (CAPA) and/or Information Security events
  • Following-up and approving Change Orders
  • Updating procedures and forms and preparing new procedures and forms
  • Performing internal audits and following-up tasks from audits, CAPAs, workplans
  • Maintaining records
  • Reporting to authorities on adverse events and files corrections
  • Providing guidance to the clinical team in managing clinical trials in compliance with ISO 14155
  • Assisting the Compliance Manager in submission to authorities (such as FDA)
  • Assisting the Compliance Manager in establishing compliance to additional regulations and standards

This position is part time:  60-80%

Requirements

Educational background

  • BSc in any field of knowledge
  • Lead internal auditor certificate, an advantage

 

Experience required:

  • 3+ years of experience in a similar function (Quality Management, Information Security Management, Regulation)
  • And 3+ years of experience on one of the following fields (advantage to candidates with experience in more than one of these fields):
  • a. Software development (system architecture, coding, V&V testing)
  • b. Product management
  • c. Medical devices
  • d. Genetics
  • e. Clinical studies
  • f.  Information Security
  • g. ISO 13485
  • h. ISO 27001
  • i.  ISO 14155
  • j.  GDPR, SOC 2
  • k.  Submissions to CE / FDA

Skills and Competencies required:

  • Excellent communication and interpersonal skills
  • Ability to perform independent work
  • Excellent writing skills in English
  • Ability to learn fast
  • Strong attention to details

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.