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- Aufgaben: Be the go-to person for regulatory matters and ensure compliance in medical tech.
- Arbeitgeber: Join a fast-growing company shaping the future of medical technology.
- Mitarbeitervorteile: Enjoy flexible hours, remote work options, and continuous training opportunities.
- Warum dieser Job: Work with a dynamic team and contribute to innovative medical technologies.
- Gewünschte Qualifikationen: Degree in medical technology or natural sciences; experience in QM/RA required.
- Andere Informationen: Flat hierarchies and a start-up mentality await you!
Das voraussichtliche Gehalt liegt zwischen 36000 - 60000 € pro Jahr.
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.
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Regulatory Affairs Specialist Arbeitgeber: EPM Scientific - Phaidon International
Kontaktperson:
EPM Scientific - Phaidon International HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Regulatory Affairs Specialist
✨Tip Number 1
Familiarize yourself with the specific regulatory standards and laws mentioned in the job description, such as ISO 13485 and the EU Medical Device Regulation. This knowledge will not only help you during the interview but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the medical technology field, especially those who work in regulatory affairs. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends and challenges in the sector.
✨Tip Number 3
Prepare to discuss your experience with regulatory databases like RAMS or EUDAMED. Be ready to share specific examples of how you've maintained compliance or contributed to approval strategies in your previous roles.
✨Tip Number 4
Show your enthusiasm for working in a dynamic environment by highlighting any past experiences where you successfully adapted to changes or contributed to process improvements. This will align well with the company's start-up mentality.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Regulatory Affairs Specialist
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Affairs Specialist position. Understand the key responsibilities and required qualifications, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in quality management and regulatory affairs. Mention specific projects or roles where you dealt with medical technology standards and regulations.
Showcase Your Skills: Clearly outline your knowledge of relevant laws and regulations such as ISO 13485 and FDA requirements. Use concrete examples to demonstrate how you've applied these in past roles.
Craft a Compelling Cover Letter: Write a personalized cover letter that reflects your motivation for applying. Discuss why you are excited about the opportunity to work in a dynamic environment and how you can contribute to the company's goals.
Wie du dich auf ein Vorstellungsgespräch bei EPM Scientific - Phaidon International vorbereitest
✨Show Your Regulatory Knowledge
Make sure to brush up on the relevant standards and regulations in medical technology, such as ISO 13485 and the EU Medical Device Regulation. Being able to discuss these confidently will demonstrate your expertise and readiness for the role.
✨Highlight Your Experience
Prepare specific examples from your past work that showcase your experience in regulatory affairs and quality management. Discuss any successful projects or audits you've been involved in to illustrate your capabilities.
✨Demonstrate Team Collaboration Skills
Since the role involves working with interdisciplinary teams, be ready to share experiences where you collaborated effectively with engineers, scientists, or other professionals. Highlight how you contributed to achieving common goals.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory strategies and future projects. This shows your genuine interest in the position and helps you understand how you can contribute to their goals.
