Regulatory Affairs Specialist – 3-year Contract

Teleflex

Regulatory Affairs Specialist at Teleflex responsible for compliance assessments of medical devices. Collaborating in multidisciplinary teams to ensure regulatory adherence in Europe and North America.

Posted 6/25/2026contractBülach • 🇨🇭 SwitzerlandJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory impact assessmentregistration of medical devicesregulatory assessmentcompliance with regulatory requirementsregulatory documentationclass II devicesclass III devicesdeficiency responsesproduct lifecycle activitiesmanufacturing changes

Soft Skills

reliable personalitycommunicative personalityattention to detailexcellent organization skillsanalytical skillsability to work in multidisciplinary teamsability to work on multiple projectsability to adapt to changestime managementproblem-solving