QA Validation Engineer
Exactech
Job Level
Mid-LevelSenior
About the role
- Prepare and coordinate regulatory submissions. These include marketing authorization applications, variations and renewals.
- Write or update technical documents related to quality (p2 or Module 3)
- Ensure regulatory compliance of veterinary medicine product information.
- Be the primary contact for responding to questions from regulatory authorities and questions regarding veterinary medicines of your region internally.
- Develop regulatory expertise in the current veterinary medicines legislation, especially with regards to the countries under your responsibility.
- Collaborate with colleagues within regulatory and outside regulatory.
- Maintain regular contact with our distributors and where necessary, local partners, for the follow-up of regulatory issues.
- Develop knowledge and understanding of each part of the registration dossier and of each regulatory submission that is done.
- Ensure regulatory compliance of our products by working closely with other departments, especially the quality assurance department.
- Submit and follow up change requests after approval of variations or other regulatory activities.
- Proofread and approve product information in our QMS or artwork system.
- Make or update regulatory affairs specifications in our QMS
- Make, review and approve work instructions and procedures related to regulatory in our QMS.
Requirements
- A degree in chemistry or life sciences is requested.
- Similar experience in regulatory affairs for human or veterinary medicines would be beneficial.
- Fluency in English
- Taste for teamwork, Work accurately, Ability to anticipate and plan
- Ability to collaborate with people from various countries and cultures.
