Description:
The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers. We are recruiting our new Senior Regulatory Affairs Specialist to join our EMEA Regulatory Affairs? team in South Africa. Let's talk about the role: As part of the EMEA Regulatory Affairs team, you will participate to all regulatory activities related to the import and distribution of ResMed products in EMEA region from product registrations to follow-up of product changes and post-market activities, with a primary focus on South Africa. You will work on EMEA processes together with other functions to ensure the overall compliance of ResMed activities in EMEA. As an expert in EMEA regulation, you will be the interface between the ResMed legal manufacturers and the country partners to ensure proper coordination. As resident of South Africa you will act as license holder and local authorized representative depute. Finally, as part of the implementation of the EMEA regulations, activities linked to the control / registration of products placed on the EMEA markets are expected. Let's talk about the responsibilities: As resident of South Africa act as license holder for ResMed and third parties’ products as well as local authorized representative depute (i.e. approval of local regulatory documentation and submission documents to local authorities). Support the implementation and maintenance of the South African quality management system in collaboration with the EMEA Quality team and UK ResMed branch. Support the local quality audits (incl. critical suppliers). Perform internal training to relevant instructions / procedures and processes. Support any regulatory request received from the field (e.g. customer, customs, authorities) Drive and manage preparation, submission, archiving and maintenance of product registrations in the European region & MENA countries to achieve timely approvals in accordance with commercial distribution and regulatory strategic plans. Communicate and interact with local regulatory partners, legal manufacturer / production sites, other on-site functions. Participate to Global regulatory projects and assessment of products changes upon legal manufacturer request. Be the key regulatory contact for South Africa and act as business partner to ensure compliance and continuity of activities. Establish and/or optimizes processes to allow regulated activities to be run efficiently and in compliance to regulation
23 Dec 2022;
from:
gumtree.co.za