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)
- 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
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