Manager of Regulatory Affairs
vor 4 Wochen
TCC GmbH is a pioneering telemedicine organization focused on enhancing digital intensive care medicine through innovative artificial intelligence solutions. We are currently seeking a Regulatory Affairs Manager to ensure our medical products adhere to both national and international regulatory standards.
Key Responsibilities:- Prepare and submit applications for medical product conformity assessments.
- Develop, review, and maintain essential regulatory documentation.
- Evaluate legislative changes and update internal protocols accordingly.
- Facilitate product approvals and registrations across various markets.
- Oversee global post-market surveillance of medical products.
- Formulate regulatory strategies tailored to our product offerings.
- Collaborate with cross-functional teams to ensure compliance.
- Implement necessary adjustments in regulatory frameworks.
- 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 industry standards.
- Familiarity with Software as a Medical Device is advantageous.
- Excellent communication and analytical skills.
- Proficiency in both German and English.
- Attractive salary package.
- Permanent employment with generous vacation allowances.
- Opportunity to influence the future within a dynamic team.
- Diverse responsibilities with opportunities for innovation.
- Job stability in a rapidly expanding sector.
- Modern office environment with flexible working arrangements.
- Hybrid working model.
- Comprehensive employee benefits.
If you are passionate about regulatory affairs and want to make a significant impact in the telemedicine field, we encourage you to consider this opportunity with TCC GmbH.
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