Senior Director, Regulatory Affairs
vor 3 Wochen
Empowering Women's Health Through Regulatory Excellence
Hologic, Inc. is seeking a highly skilled Senior Director, Regulatory Affairs to join our team. As a leading innovator in women's health, we are committed to delivering innovative solutions that improve lives.
The successful candidate will be responsible for leading our international regulatory affairs team, ensuring compliance with local and regional registration requirements, and developing strategies for timely submissions and approvals.
Key Responsibilities:
- Lead the development and implementation of global regulatory strategies
- Manage international regulatory activities for new and mature products
- Provide counsel to the Regulatory Affairs team on regulatory requirements and submissions
- Develop and maintain department budgets across multiple regions
- Interact with regulatory agencies to achieve company goals and objectives
Requirements:
- Minimum technical/advanced degree in science or law
- EU and global submissions experience required
- Regulatory Affairs Certified (RAC) preferred
- Strong knowledge of regulatory requirements related to ISO 13485, EU MDR/IVDR, and global regulations
What We Offer:
- A dynamic work environment where your ideas lead to tangible impacts
- Competitive salary and benefits package, including health insurance
- Opportunities for professional growth and development within a global company
Join us in shaping the future of women's health.
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