Regulatory Affairs Manager (f/m/x) Medical Devices
Regulatory Affairs Manager (f/m/x) Medical Devices
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Job Description
We have revolutionized allergy diagnostics and have been operating successfully in more than 90 countries for over 9 years with our diagnostic products and patented technologies. Our products help clarifying allergies in a single step for humans and animals alike. Allergies are diagnosed in a highly specific manner so that patients receive help by their specialist in no time. We increase quality of life enable personalized treatment advance research and relieve our health system.
We offer:
A full-time position flexible working hours home office if necessary
Annual pass for Viennas public transport and Sodexo vouchers
Collaboration with people who care about human and veterinary patients alike
An environment where you feel empowered to ask questions make requests and offer ideas
An atmosphere created by the thoughts of sustainability equity diversity inclusion and mutual respect
We need you for:
Preparing technical documents to support country-specific regulatory submissions of registration documents and maintaining reviewing and updating regulatory submissions and documents
Evaluating regulatory input for CAPAs changes deviations
Assisting in responses to regulatory authorities notified bodies and authorized representatives questions within assigned timelines
Supporting internal and external audits and inspections
Serving as the companys Data Protection Officer: ensuring compliance with applicable data protection regulations
Establishing maintaining and regularly updating the company-wide Legal Register including systematic identification and evaluation of relevant legal requirements
Carrying out post-market surveillance activities and preparing work instructions (SOPs) and forms
Your profile:
Degree in medical technology biology biochemistry or comparable course of study
Minimum of 4 years of experience in regulatory affairs in the context of (in-vitro diagnostic) medical devices (e.g. MDR IVDR)
Advantageous: Experience with regulations and registrations in USA Canada and/or Japan
Accuracy willingness to learn and the ability to work independently competence to work in a team
Very good command of German and English
For the cooperation in our team we offer a payment in line with collective agreement (KV Handwerk und Gewerbe) based on a full-time position. Your actual salary depends on your previous experience and qualifications. Ready to become part of the MADx team Then apply with your CV!
Employment Type
Full Time
