Regulatory Affairs Lead

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 play a pivotal role in ensuring adherence to both national and international regulatory standards for our medical innovations.

Key Responsibilities:
  • Oversee the preparation and submission of regulatory applications for medical product conformity assessments.
  • Develop, review, and maintain comprehensive regulatory documentation.
  • Conduct legislative analysis and update internal compliance protocols accordingly.
  • Facilitate product approvals and registrations across various markets.
  • Monitor and manage post-market surveillance for medical products on a global scale.
  • Formulate regulatory strategies that align with our product development goals.
  • Collaborate effectively with cross-functional teams to ensure regulatory compliance.
  • Implement necessary adjustments in response to evolving regulatory guidelines.
Required Qualifications:
  • A degree in a relevant discipline, such as medical technology or a related field.
  • Proven experience in regulatory affairs, particularly with 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 problem-solving skills.
  • Proficiency in both German and English is essential.
What We Offer:
  • A competitive salary package.
  • A permanent position with generous vacation benefits.
  • The chance to influence the future within a dynamic and motivated team.
  • Diverse responsibilities that encourage innovative thinking.
  • Job security in a rapidly expanding sector.
  • Modern office environment with flexible working arrangements.
  • A hybrid work model to support work-life balance.
  • Comprehensive employee benefits.

If you are interested in contributing to our mission, we encourage you to submit your resume in the specified format. Join TCC GmbH and make a significant impact in the field of telemedicine.

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