Regulatory Affairs Manager
Location: GermanySIRE 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!
THE COMPANY
Our client is a professional Medical Devices organization, based in Germany.
My client is a growing medical device company headquartered in Bayern. It focuses on the production of medical orthopedic products. As soon as possible, a Regulatory Affairs Manager is needed to strengthen their department.
ROLE DESCRIPTION
You are responsible for the authorization/certification/obtaining markings of products as well as activities contributing to the development of projects.
RESPONSIBILITIES
- Processing of authorizations of medicinal products
- Ensuring that the correct regulatory requirements (MDD) have been established in the development fase and change process
- Cooperation with the development department, in order to guarantee a quick launch
- Participation in the CAPA handling
- Creating technical documentation
REQUIREMENTS
- Successfully completed technical studies
- Experience in the approval of medical products (CE). Skills for approvals in Asia and South America are beneficial
- Knowledge of all important standards and regulations
- Very good German and English skills
- Strong analytical skills, teamwork and high self-motivation
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Michael Lynch.
