Junior Regulatory Affairs Specialist

Teleflex Incorporated; Bülach; Vor Ort; CHF 75’000 - 95’000; Vollzeit

Zusammenfassung

A global provider of medical technologies seeks a dedicated team member for regulatory affairs to assist in product registration and maintain documentation for innovative vascular intervention devices. This role requires a university degree in a relevant field, teamwork, analytical skills, and fluency in English, with proficiency in German being a plus. Knowledge of Microsoft Office and SAP is preferred. Join a company focused on improving healthcare through diversity and inclusion.

Qualifikationen

• One year of experience with registrations of medical devices is a plus.
• Fluency in English is mandatory; German and any additional language are an advantage.

Aufgaben

• Supporting product registrations in low-effort countries.
• Maintaining the project status of registrations in the regulatory database.
• Assessing and clarifying requirements for new device registrations.

Kenntnisse

Microsoft Office

Adobe applications

Analytical skills

Teamwork

Attention to detail

Ausbildung

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

Tools

SAP

Jobbeschreibung

About Teleflex Incorporated

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. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Position Summary

This role will be located at the Bulach, Switzerland location which is responsible for the development, production and marketing of balloon catheters and drug-coated stent systems.

We are seeking a new team member for our Vascular Intervention (VI) regulatory affairs group. The regulatory affairs department is responsible for worldwide registration of the newly developed class II and III innovative products and the existing portfolio.

Principal Responsibilities

• Supporting product registrations in low-effort countries
• Maintaining the project status of registrations in the regulatory database, change projects overview and documentation overview
• Supporting the worldwide assessment of changes
• Maintaining regulatory documentation up to date for global registrations
• Assessing and clarifying the requirements for new Vascular Intervention device registrations and the regulatory impact of changes in assigned low-effort countries
• Staying up to date with the latest regulatory requirements in assigned countries

Education / Experience Requirements

• University degree in natural sciences, pharmacy, pharmacology, medicine or engineering
• One year of experience with registrations of medical devices is a plus
• Literate in Microsoft Office and Adobe applications; SAP knowledge is an advantage
• Ability to work in a team, attention to detail, analytical skills, excellent organizational skills and ability to work on multiple projects with tight timelines
• Ability to adapt to program/timeline changes as needed
• Fluency in English is mandatory; German and any additional language are an advantage

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’s 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.