We are looking for ambitious and motivated individuals who enjoy working in a dynamic and fast-growing environment. Together we want to further expand our customer and product portfolio and actively shape the future of medical technology.
Regulatory Affairs Specialist (m/w/d)
Your tasks:
- Internal contacts for regulatory matters.
- Monitoring regulatory and legal requirements of target markets.
- Compilation and preparation of approval documents/technical documentation within the framework of international approvals.
- Maintaining regulatory compliance and maintaining applicable and applied standards and legal requirements (standards research).
- Annual update of Establishment Registration and Product Licenses for Canada and USA.
- Responsible for the maintenance, creation, and updating of data within regulatory databases such as RAMS/DIMDI/EUDAMED/GUDID.
- Support in the development of approval strategies for global approvals, process improvements, and audits.
- In addition, support our interdisciplinary teams in regulatory matters.
Your profile:
- Successfully completed degree in medical technology or natural sciences or training as a foreign language correspondent or similar.
- Several years of experience in the QM/RA area.
- Knowledge of standards, laws, and regulations of medical technology (ISO 13485, Directive 93/42/EEC, REGULATION (EU) 2017/745, MPG, MPV, MPSV, IEC 60601-1-ff, FDA, Canada, etc.).
- Experience with external audits is an advantage.
What can you expect?
- Innovative working environment with flat hierarchies and start-up mentality.
- Opportunity to actively develop and design new technologies in the field of medical technology.
- Direct collaboration in an interdisciplinary team of engineers, scientists, and medical technology experts.
- Flexible working hours, home office options, and family-friendly working conditions.
- Continuous training and individual development opportunities.
