Aktuelle Jobs im Zusammenhang mit Senior Director of Regulatory Compliance and Quality Assurance - Tübingen, Baden-Württemberg - ACE Partners
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Senior Director of Regulatory Compliance and Quality Assurance
vor 2 Monaten
Transformative Leadership Opportunity
About ACE Partners :
We're a leading global Medical Device company specialising in Class III Cardiovascular Devices. Our innovations significantly impact patient outcomes, and we are at the forefront of the industry in both Europe and the U.S.
Position Overview :
We are seeking a dynamic Executive Vice President of Regulatory Affairs and Quality Assurance to lead global regulatory and quality operations. This role will focus on driving a cultural transformation, harmonising our Quality Management System (QMS) across regions, and ensuring compliance with global standards.
Key Responsibilities :
- Leadership & Strategy : Implement and align global regulatory and quality strategies with corporate goals, fostering a culture of compliance and excellence.
- Regulatory Affairs : Oversee global regulatory compliance, including FDA and DEKRA, manage regulatory submissions for Class III cardiovascular devices, and lead interactions with regulatory bodies.
- Quality Assurance : Harmonise the QMS globally, prepare for FDA inspections, and drive continuous improvement initiatives.
- Team Development : Mentor and lead a global team, ensuring alignment with corporate objectives and promoting a culture of growth.
Qualifications :
- Senior leadership experience in Regulatory and Quality roles within the medical device industry, must have with Class III devices.
- Strong knowledge of global regulatory requirements, including FDA.
- Proven ability to lead cultural change and harmonise international operations.
- Excellent leadership, communication, and cross-functional collaboration skills.
Why ACE Partners :
Lead transformative change in a company at the cutting edge of Cardiovascular medical devices, with significant global growth opportunities. Competitive compensation, including relocation support, 30 holidays, and a company car.
