Koch
Join our Talent Network
Skip to main content

Regulatory Coordinator

 

Description

Are you committed to ensure that medical devices placed on the market are safe and effective, interested to work in a challenging regulatory environment involving interface with drug regulations, and willing to enter the regulatory field or expend your knowledge?

 Do you want to be part of a team responsible for the development, registration and post-market activities related to combination products worldwide?

 Then you may be the person we are looking for to join our growing team in Phillips-Medisize’s Global Innovation & Development Center based in Virum and Struer.

What You Will Do In Your Role

As a Regulatory Coordinator you will

  • Support the regulatory team in the following regulatory activities related to registration:
  • Contracting, managing, and reporting in relation to in-country representatives.
  • Recording and keeping track of costs & timeline for registration based collected data.
  • Handling translation and authentication of regulatory statements and certificates.
  • Handling practicalities related to technical document submission.
  • Archiving documentation related to interaction and approval from Heath Authorities.
  • Keeping Regulatory Information Management Platform up to date.
  • Capture and process lessons learned for each performed submission.

 Support the regulatory team in the following activities related to processes and projects:

  • Update procedures and templates to include requirements related to new countries.
  • Update procedures and templates to reflect changes in the regulatory environment.
  • Review projects’ regulatory documentation to support projects, if required.
  • Author projects’ regulatory documentation to support projects, if required.

The Experience You Will Bring

Requirements:

  • Bachelor’s degree, either science, biomedical or engineering is preferred
  • Systematic, rigorous, and structured thinking and documentation.
  • Strong collaboration and organizational skills, and the ability for multi-tasking.
  • Pro-activity, self-drive and commitment to process improvement.
  • Ability to work in an evolving, challenging, and multi-disciplinary environment.
  • Excellent written and verbal communication skills in English.
  • Proficiency with MS Office.

What Will Put You Ahead

  • Experience in a similar position
  • Knowledge of the regulatory environments for medical devices

#LI-IB1

Sign up for our talent network.

Not ready to apply? Take a minute to sign up to receive notifications on opportunities that match your interests.

Sign Up Now