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
- 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