Team Lead - Regulatory Affairs (m/f/d)

Team Lead - Regulatory Affairs (m/f/d)

Abbott Laboratories | Yonkers, NY, 10701, US

Posted 4 days ago

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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional's and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

The Opportunity

The Team Lead - Regulatory Affairs works out of our site in Jena in the Abbott Rapid Diagnostics Division (Abbott RDx internal title: Regulatory Affairs Supervisor)

What you´ll do…

* 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

Required Qualifications and Skills

* 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

Preferred Qualifications and 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

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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.

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