For our client, a Medical Device company which produces biomedical laboratory instruments, we are currently looking for this permanent position in Munich:
Senior Analyst, Regulatory Affairs (m/f/d)
- Working within the Workflow and IT Solutions (WITS) Quality RA organization, the Senior Analyst Regulatory Affairs reports directly to the WITS Manager, Regulatory Affairs.
- He/she ensures compliance of the products and the regulatory processes and supports Automation and Informatics product lines.
- Ability to work in a matrix and multicultural environment to drive improvement and simplification.
- Ensures product and processes compliance.
- Defines product registration strategy and drives communication with competent authorities.
- Supports new product development as RA Core Team member.
- Supports post launch design change process.
- Coordinates post market regulatory activities.
- Drives improvement of local and global processes associated to regulatory.
- 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 7 years +
- Excellent communication skills and team work.
- Excellent practical experience of IVD regulations including but not limited to US, EU, Canada, and China.
- Strong risk management experience per ISO14971.
- Knowledge of IEC 60601 / IEC 61010 3rd Edition, IEC 62366 and IEC 62304, and software cyber security and privacy is a plus.
- Experience in post market activities; recall management and adverse event reporting.
- Experience in post launch design changes.
- 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).