Key skills
R
About this role
Role Overview
- Assessment of design and manufacturing changes to ensure compliance with regulatory requirements and that sufficient information is available to perform the regulatory impact assessment of the change
- Coordinate and contribute to worldwide assessment of changes and support the related product and production lifecycle activities
- Maintain regulatory documentation up to date for worldwide regulatory purposes
- Support the registration of changes for class II and III devices in the CE, US, Japan and other highly regulated countries
- Coordinate and submit deficiency responses to relevant certification bodies and country authorities
Requirements
- University degree in natural science, pharmacy, pharmacology, medicine or engineering
- At least 2 years of experience with the registration of medical devices and regulatory assessment of changes in Europe and other highly regulated countries
- Literate in Microsoft Office and Adobe Acrobat applications
- Reliable and communicative personality
- Ability to work in multidisciplinary teams with different backgrounds (R&D, Production, Quality, Marketing, Clinical)
- Attention to details, excellent organization and analytical skills, and ability to work simultaneously on multiple and sometimes urgent projects with tight timelines.
- Ability to adapt to program/timeline changes as needed
- Fluency in English is mandatory.
Benefits
- Teleflex is an equal opportunity employer.
- Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community.
- Diversity fosters innovative thinking and entrepreneurship.