Regulatory Affairs Coordinator
vor 4 Wochen
TCC GmbH is a pioneering telemedicine organization focused on delivering advanced digital intensive care solutions through the integration of artificial intelligence. We are currently seeking a Regulatory Affairs Manager to play a vital role in ensuring our medical products adhere to both national and international regulatory standards.
Key Responsibilities:- Oversee the preparation and submission of applications for conformity assessments related to medical products.
- Develop, review, and maintain comprehensive regulatory documentation.
- Evaluate legislation and update internal protocols accordingly.
- Facilitate product approvals and registrations.
- Conduct global post-market surveillance of medical products.
- Formulate regulatory strategies to support our product offerings.
- Engage collaboratively with various departments.
- Implement necessary adjustments in regulatory guidelines.
- Bachelor's degree in a relevant discipline, such as medical technology.
- Proven experience in regulatory affairs and securing international market approvals.
- In-depth knowledge of medical device regulations and standards.
- Familiarity with Software as a Medical Device is advantageous.
- Excellent communication and problem-solving abilities.
- Proficiency in both German and English.
- Attractive salary package.
- Permanent employment with 30 days of vacation.
- Opportunity to influence the future within a dynamic team.
- Diverse responsibilities with opportunities for innovation.
- Job stability in a rapidly expanding sector.
- Modern work environment with flexible hours.
- Hybrid working model.
- Comprehensive employee benefits.
If you are passionate about regulatory affairs and want to contribute to our mission, we encourage you to consider this opportunity with TCC GmbH.
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