25 km

Abbott Rapid Diagnostics Jena GmbH


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Team Lead - Regulatory Affairs (m/f/d)
Aktualität: 22.11.2022


22.11.2022, Abbott Rapid Diagnostics Jena GmbH
Team Lead - Regulatory Affairs (m/f/d)
Manage the Abbott Jena Regulatory Affairs department including overseeing day-to-day operations and management of personnel Provide regulatory knowledge and guidance on IVDD, IVDR and applicable German regulations to the Abbott Jena site and on international level Regulatory contact point for notified bodies and authorities Coordinate and support regulatory requests and determine required regulatory actions Provide program and project management support to wider regulatory projects under the direction of the Regulatory Manager Coordinate worldwide registrations of Abbott products in cooperation with local/regional regulatory affairs Implement regulatory requirements incl. new standards, laws, and regulations for Abbott products
Minimum of a bachelor's degree (BA/BS) from an accredited University Minimum of 3 years of experience in Regulatory Affairs role within a regulated industry (Medical Device/IVD/Pharma/GMP/Biotech) Experience in people/team management Strong written and verbal communication skills, both in English and German Strong stakeholder and project management skills Good understanding of IVD regulation Experience in managing multiple projects and cross functional teams Ability to adapt quickly and effectively to shifting priorities Very strong attention to detail Positive mindset and ability to drive motivation We ask for your understanding that we only consider online applications via our online application portal. Applications by email or post cannot be processed. Original documents will not be returned.