Regulatory Affairs Specialist

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.