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Regulatory Affairs Director

vor 2 Monaten


Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit
Job Description

Job Title: Regulatory Affairs Director

Company: PAUL HARTMANN AG

Location: Remote

Job Type: Full-time

About Us:

PAUL HARTMANN AG is a leading international medical technology company that develops and manufactures high-quality medical products. We are committed to supporting healthcare professionals in their daily work and to improving the quality of life for patients.

About the Role:

We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with all regulatory requirements for our medical products in all relevant markets.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with all relevant regulations and standards.
  • Lead a team of regulatory affairs specialists to ensure effective implementation of regulatory strategies.
  • Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
  • Stay up-to-date with changes in regulatory requirements and ensure that our products and processes are compliant.
  • Develop and maintain relationships with regulatory authorities and industry stakeholders.

Requirements:

  • At least 5 years of experience in a regulatory affairs role within a medical device company.
  • Strong knowledge of regulatory requirements for medical devices, including EU and US regulations.
  • Excellent communication and project management skills.
  • Fluent English and German language skills.

What We Offer:

  • A competitive salary and benefits package.
  • The opportunity to work with a leading international medical technology company.
  • A dynamic and supportive work environment.
  • The chance to develop your skills and expertise in regulatory affairs.