Abbott is a global healthcare company committed to helping people live not just longer, but better. We employ around 99,000 people in 150 countries with a diverse portfolio spanning pharmaceuticals, nutrition, diagnostics and devices.

Across our office in Heerlen we continue to innovate and to solve complex challenges within the healthcare industry while planning exciting developments that lie ahead. At the moment we are looking for a Regulatory Affairs Specialist to join us on a full-time basis.

Would you like to be a part of an instrumental team within the Regulatory Affairs in charge or creating new solutions, challenging the current processes and brining new ideas to the table? Then this is the role for you!

You will connect with different departments across different layers within our organization and be one of the main point of contacts for the Regulatory Affairs and compliance matters. Moreover, you will be a part of a dynamic team within a motivating and inspiring environment at one of the top employers within the healthcare industry.

PRIMARY JOB FUNCTION

•           Functional support for AVIO EMEA Regulatory Compliance and the AVN distribution center regarding local regulatory affairs & compliance.

•           Functional counterpart for AVN & AVIO EMEA RC with AV Divisional Regulatory Affairs

•           Continuously evaluates current and anticipated future European regulatory requirements to determine the impact and to be pro-active in implementing programs to be in compliance with applicable legislation.

CORE JOB RESPONSIBILITIES:

•           EU MDR Regulatory Affairs support

•           Verification activities on behalf of the Abbott Authorised representative, The importer and the Distributor

•           Other support activities in light of EU MDR (EUDAMED registration, support for Authorised rep and PRRC)

•           RA representative in the European Union related to EU MDR

•           Regulatory Affairs activities like impact assessments & connecting with divisional RA for EMEA (including AVN) projects

•           AVN DC Regulatory Affairs liaison for regulatory aspects (like PRA, new product submissions, audit support)

•           Regulatory Compliance (procedures, employee trainings, etc.)

Knowledge, skills and experience:

•           Bachelor’s or Master’s Degree in engineering or similar technical field

•           Knowledge of medical device related regulation like EU MDR, GDP

•           Understanding of Regulatory Affairs in Medical Device/Pharmaceutical Environment

•           Knowledge of operations, logistics, manufacturing practices and ERP systems.

•           Lean (Six-)Sigma Experience

•           Experience with regulatory databases & tools and techniques

•           Ability to travel internationally

•           Organized with a high attention to detail

•          Out of the box thinker with a go getter mentality

•          Fluent in Dutch and English (verbally and in writing)

WHAT CAN WE OFFER YOU?

Abbott provides a varied, challenging and international position in a dynamic and pleasant working environment. In our organization, you can count on excellent primary and secondary benefits, a positive working atmosphere, a personal growth plan, extensive training opportunities and good career perspective. We are in the business of advancement, both in health solutions and in the lives and careers of our employees. Our work across the world and in many areas of healthcare provides a rich environment for our employees to explore career paths, interests and opportunities.

HOW TO APPLY?     

If you are appealed by Abbott, looking for a job with meaning and recognize yourself in the outlined profile, please make your interest known. You can apply via our website (https://www.jobs.abbott/) with your resume and letter of application. Please let me know if you have any questions or comments referring this job profile to Valeria Calenici, recruitment.netherlands@abbott.com