Senior Regulatory Affairs Officer

vor 4 Wochen

Hamburg, Hamburg, Deutschland TCC GmbH Vollzeit
Regulatory Affairs Manager

TCC GmbH is at the forefront of telemedicine, leveraging advanced artificial intelligence to enhance digital intensive care medicine. We are seeking a Regulatory Affairs Manager to ensure our medical products adhere to both national and international regulations.

Key Responsibilities:
  • Prepare and submit applications for medical product conformity assessments.
  • Develop, review, and maintain essential regulatory documentation.
  • Interpret legislation and update internal compliance guidelines accordingly.
  • Facilitate product approvals and registrations.
  • Oversee global post-market surveillance of medical products.
  • Formulate regulatory strategies for product development.
  • Collaborate effectively with cross-functional teams.
  • Implement necessary changes in regulatory frameworks.
Required Qualifications:
  • 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 analytical skills.
  • Proficiency in both German and English.
What We Offer:
  • Attractive salary package.
  • Permanent employment with generous vacation allowance.
  • 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.

Join TCC GmbH and contribute to our mission of advancing telemedicine.

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