Regulatory Affairs Director
Vor 5 Tagen
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.
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