Senior Regulatory Affairs Specialist 1

Jobangebot - BIOTRONIK SE & Co. KG

Connecticum Job-Nr. 1434257 / 44561
  • Arbeitgeber: BIOTRONIK SE & Co. KG Firmenprofil
    Beschäftigungsart: Professionals Job
    Jobdatum: 14. September 2021
    Fachbereiche: Ingenieurwissenschaften: Allg. Ingenieurwissenschaften
    Naturwissenschaften: Pharmazie
    Sonstige: Humanmedizin
    Einsatzort: 8180 Bülach, Schweiz; Europa-Mitte

    Senior Regulatory Affairs Specialist 1 - Jobangebot


    Senior Regulatory Affairs Specialist

    As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

    We are seeking a new team member for our Vascular Intervention (VI) regulatory affairs department. The regulatory affairs department is responsible for registration in highly regulated markets of the newly developed products and the existing portfolio. With newly developed class III innovative products, the regulatory affairs department offers an excellent opportunity to work on challenging regulatory submissions.

    Your Responsibilities

    • Being responsible for regulatory aspects during the development of new VI products (regulatory strategy, applicable standards and guidelines)
    • Registration of class III devices in the CE, US, and other highly regulated countries
    • Coordinating and submitting deficiency responses to relevant certification bodies and country authorities
    • Maintaining regulatory documentation up to date for worldwide regulatory purposes
    • Worldwide assessment of changes and support production lifecycles activities
    • Establishing and updating internal procedures to enable up to date and consistent output, as well as efficient workflow within the department and project team

    Your Profile

    • University degree in natural science, pharmacy, pharmacology, medicine or engineering
    • At least 4 years of experience with registrations of class 3 medical devices including drug-device combination products in highly regulated countries, particularly in the CE region and the USA.
    • Excellent knowledge of the applicable medical device regulations in the countries mentioned above, including current developments (MDR)
    • Experience in project management
    • Literate in Microsoft Office applications; SAP knowledge is an advantage
    • Independent, reliable and communicative personality who can deliver high-quality work even under pressure and handle several projects simultaneously
    • Fluency in the English language mandatory, German and any other language an advantage

    In addition to our employee benefits, you will also have the advantage of flexible working hours, the possibility to work in a home office, and a central workplace in Bülach, Zürich.

    Are you interested in hearing more? Please send us your CV and, if possible, a cover letter highlighting how your qualifications correlate to the skills and experience needed for the advertised position opening.

    Thank you for applying via our application management system. We are looking forward to talking to you!

    Location: Bülach, Zürich | Working hours: Full-time | Type of contract: Unlimited

    Apply here: | Job ID: 44561

    - Only direct applications via our application management system will be considered -

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Bitte bei Bewerbung angeben:

Senior Regulatory Affairs Specialist 1

Jobkennzeichen Connecticum Job-Nr. 1434257 / 44561
Arbeitgeber-Profil: BIOTRONIK