A LITTLE ABOUT US

Abbott is a global health care company devoted to improving life through the development of products and technologies in health care.  With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritional and branded generic pharmaceuticals, Abbott serves people in more than 160 countries and employs approximately 110,000 people.

ABOUT ABBOTT VASCULAR NETHERLANDS (AVN)

Abbott Vascular Netherlands in Heerlen, is one of the two Abbott Vascular Tier 1 distribution centers responsible for the worldwide distribution of Abbott’s vascular products. From our 10,000 m2 warehouse we ship an average of 1,700 deliveries per day (+/-700,000 units per month) to hospitals, Abbott distributors, Abbott affiliates in Europe, the Middle East, Africa, and South America.

Every day, more than 150 employees in our warehouse and in supporting departments work on processing customer orders, maintaining a high service level to ensure that our customers receive the right products on time. Abbott Vascular Netherlands offers a complete and high-standard Supply Chain solution, including an extensive range of value-add logistics activities such as labeling, relabeling, and reworking of products to meet country-specific needs.

PRIMARY JOB FUNCTION

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

• Functional counterpart for AVN & EMEA RC with 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.

WHAT WILL YOU BE RESPONSIBLE FOR?

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

• Other support activities in light of EU MDR (EUDAMED registration, support for Authorized 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

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

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

A LITTLE ABOUT YOU

• You have min. a Bachelor’s Degree in engineering or similar technical field

• You have experience within change Management / Lean certification is a preferred

• Certifications in Quality Systems / Auditing / CAPA / Change Management

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

• Fluent in English and Dutch (other languages are a plus)

• Ability to travel internationally