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Regulatory Affairs Manager
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Medical Devices organization, based in Switzerland.
Our client is based in the northern part of Switzerland and manufacturers Medical Accessories that connects Medical Devices to patients and transfers bio-electric signals. The company has more than 35 years of experience in successful medical accessory innovation, development, manufacturing, and commercialization. The medical accessories are marketed worldwide.
The Regulatory Affairs Manager is closely working together with the R&D and engineering team in order to deliver compliant complex medical devices. The Regulatory Affairs Manager will be participating in the early phase stage of the development of new medical devices. You will ensure quality and regulatory aspects from early phase design, to design to manufacturing. You will make sure that the Design History files and validations are according to applicable standards and requirements in order to fulfill customer satisfaction and compliancy to the different institutions. You will be responsible to determine the path for submissions of new products and changes to these products. You will execute such submissions in the EU and with the FDA. You will support customers with submissions in other world-wide regions.
- Maintain registrations and submitting new registrations (FDA/MDD)
- Coordinate, implement and monitor Regulatory Activities
- Responsible for meeting and/or exceeding requirements for the technical file
- You approve all relevant documents, tests, validations in order to meet project requirements, and are able to make choices and defend decision
- Promotes Regulatory Affairs awareness throughout company
- Continuous improvement on the field of RA and QA
- You will report to the RA Country Director
- 5-10 years of relevant experience with an Academic degree, preferably a Technical background
- You gained expertise in the Medical Devices Industry, preferably with Design Assurance or Engineering background (early phase development)
- Good knowledge and experience with 510(k) and CE submissions
- Good understanding and knowledge of FDA regulations, ISO 13485, MDD 93/42 (other regulations are considered a plus)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.