Associate Regulatory Affairs Specialist

Teleflex; Zürich; On-site; CHF 90,000 - 130,000; Full time

Job summary

Teleflex in Zürich, Switzerland seeks a Regulatory professional to ensure vascular intervention medical devices are developed, manufactured and registered in line with global healthcare laws. You will manage regulatory assessments of changes and maintain worldwide documentation.

Responsibilities include design/manufacturing change assessment, supporting CE/US/Japan registrations, coordinating deficiency responses, and keeping documentation up to date.

Qualifications

• University degree in natural science, pharmacy, pharmacology, medicine or engineering.
• At least 2 years of experience with registration of medical devices and regulatory assessment of changes in Europe and other highly regulated countries.
• Fluency in English is mandatory; literate in Microsoft Office and Adobe Acrobat.

Responsibilities

• Assess design and manufacturing changes for regulatory impact and compliance.
• Coordinate worldwide assessment of changes and support product lifecycle activities.
• Maintain regulatory documentation up to date for worldwide purposes.
• Support registration of changes for class II and III devices (CE, US, Japan, etc.).
• Coordinate and submit deficiency responses to authorities and certification bodies.

Skills

Regulatory knowledge

Attention to detail

Analytical skills

Multidisciplinary teamwork

Project management

Education

University degree in natural science, pharmacy, pharmacology, medicine or engineering

Tools

Microsoft Office

Adobe Acrobat

Job description

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As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Position Summary

In regulatory we are responsible for ensuring that vascular intervention medical devices are developed, manufactured, and distributed in strict compliance with global healthcare laws registrations and for submission and approval in highly regulated countries including Europe, US and Canada.

• 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 IIIdevices in the CE, US, Japan and other highly regulated countries
• Coordinate and submit deficiency responses to relevant certification bodies and country authorities

Education / Experience 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

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.

If you require accommodation and support to apply for a position, please contact us at [e-mail]

Diversity fosters innovative thinking and entrepreneurship and that is what we are about at Teleflex. We trust and value our people and their diversity and we make it fun to work here. We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in. Our approach is simple, we embrace everyone and want them to feel they belong here. We are building a culture where all employees can bring their best and unique selves to work. If that appeals to you, we would love to hear from you. Come join a company where diversity is sought out and inclusivity is how we progress.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.