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.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
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That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
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