For our client, a leading Biotech company who develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing, we are currently looking for this permanent position in Munich:
Staff Regulatory Affairs (m/f)
- Working within the Workflow and IT Solutions (WITS) Quality RA organization, the Staff Regulatory Affairs reports directly to the WITS Director, Quality Regulatory Affairs. ;
- He/she ensures compliance of the products and the regulatory processes and supports Automation and Informatics product lines.
- He /she interacts collaboratively with the Product Compliance Group, to ensure the type testing certification such as electrical and electromagnetic compatibility and also compliance to product specific directives such as restriction of Hazardous Substances (RoHS) are in place, and with the Development Group to make sure that applicable standards are met (such as Software development lifecycles and Usability engineering).
- He/she is able to work in a matrix and multicultural environment to drive improvement and simplification.
- Specific Responsibilities:
- Ensures products and processes compliance.
- Defines products registration strategy and Drives communication with competent authorities.
- Coordinates post market activities.
- Drives improvement of local and global processes associated to regulatory processes.
- Bachelor/Master degree in sciences, life sciences, engineering, software development or equivalent education gained through work experiences.
- Successful experience in pre and post-market regulatory affairs in Medical device/IVD industry of 10 years +
- Excellent communication skills and team work.
- Excellent practical experience of IVD regulations including but not limited to US, EU, Canada, Japan.
- Knowledge of ISO14971, IEC 60601 / IEC 61010 3rd Edition, IEC 62366 and IEC 62304. Software cyber security and privacy.
- Ability to work cross culturally/functionally and understand functional department requirements.
- Proficient in English.
- Excellent organizational capabilities.
- Highly ethical, is able to multi-task and prioritize in a competitive environment.
- Computer skills (MS Office products).
- Clean driving record ? ability to travel as required (may include international travel).