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Home-Use Device & Cosmetics Regulation Affairs Manager

Basic Job Purpose:

Actively contribute to the development and implementation of regulatory activities for assigned projects and products.

Maintain all company products submissions in all relevant markets and territories (APAC – Advantage)

Main Duties:

  • Member of the company regulatory team
  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners
  • Prepare and coordinate regulatory submissions (e.g., IMOH, Health Canada, FDA, CE, etc.) in accordance with applicable regulations.
  • Prepare or maintain technical files and cosmetic PIFs as necessary to obtain and sustain product approval.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Assisting all departments in the organization, such as R&D, Clinic and Marketing, from regulatory aspects from product definition to release.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents

Requirements:

At least 3 years of relevant experience within the regulatory affairs disciplines in cosmetics registration and/or home-use device regulation

  • Knowledge of relevant standards, such as FDA 21 CFR 820, ISO 13485, MDD, MDR, MD-SAP, IEC 60601 SERIES
  • Regulatory experience in cosmetic/medical equipment companies and familiarity with FDA requirements, European Directive and Canadian requirements
  • Experience in submissions and familiarity with the requirements of APAC countries – an advantage
  • Responsible, self-motivated, organized and meticulous
  • Able to multitask and meet the targets set
  • Fluent in English, Excellent expression skills – written and verbal
  • Other languages – an advantage

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