Overview

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, nutritionals
and branded generic medicines. Our 113,000 colleagues serve people in more than
160 countries.
TEAM LEAD – REGULATORY AFFAIRS (M/F/D)
LOCATION: GERMANY – JENA
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.
APPLY NOW
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and
on Twitter @AbbottNews and @AbbottGlobal.