Your new company
The Regulatory Compliance Associate supports the business in achieving successful and timely product launches in the global markets, working collaboratively within the company, and with its affiliates and external partners, to secure and maintain market access for the products it manufactures and/or distributes.
Your new role
* Establish and maintain a central record of current global market clearance/registration status for Lansinoh's Cosmetics, Medical Devices, OTC, and consumer products, and any new technologies acquired or developed.* Establish and maintain a central repository of the current and core technical documentation and data generated or received in support of product registrations/clearances.
* Coordinate the timely acquisition, and provision of technical documentation upon request from Regulatory Authorities, Distributors and in-country agents, working with the original manufacturers to customize the documentation as necessary to meet market-specific requirements.
* Supporting New Product and Business Developments with analysis of the regulatory landscape and pathway for new products/technologies, identifying key documentation and data requirements, submission strategies, timelines and associated costs.
* Facilitate new product registrations as well as renewals, as required.
* Review and approve artwork and labelling for compliance with market regulatory requirements.
* Develop an up-to-date knowledge and understanding of the governing market regulations for the products we manufacture and/or distribute, utilizing where necessary self-training opportunities, consultation with regulatory authorities, or advice and direction from external legal counsel and consultants.
What you'll need to succeed
* 1-3 years of experience in a similar role within the Medical Device or Cosmetics industry.* Experience with regulatory labeling requirements for Medical Devices or Cosmetics.
* Experience in establishing and maintaining centralized documentation and data repositories.
* Experience working within multi-functional project teams, and with external manufacturers, distributors, consultants and market regulatory authorities.


What you need to do now


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