Senior Director, Regulatory Affairs Lead
Vor 3 Tagen
As a leading innovator in women's health, Hologic is empowering people to live healthier lives everywhere, every day. Our regulatory affairs team is responsible for staying up-to-date on new, changing, and existing regulatory requirements. They develop and implement a global vision for regulatory affairs to influence strategic and operational plans.
Key Responsibilities
- Hold accountability for the success of International Regulatory Affairs, working with divisional partners and international leadership to develop and meet organizational goals.
- Partner with Hologic design centers and legal manufacturers to ensure timely preparation of organized and scientifically valid applications.
- Assess and interpret regulatory guidance and requirements into practical, workable, global registration strategies.
- Develop and maintain department budget across multiple regions.
- Interact with regulatory agencies as needed to accomplish company goals and objectives.
- Provide direction to senior management in various areas, groups, and/or operations.
- Operate as an influential leader.
Requirements
- Preferred Minimum Technical/Advanced Degree: Bachelor's degree in science or law.
- EU and global submissions experience required.
- Regulatory Affairs Certified (RAC) preferred.
- Solid working knowledge of the regulatory requirements related to ISO 13485, EU MDR/IVDR, and relevant global regulations related to medical devices and IVDs.
- Strong knowledge in medical device and IVD Design Controls and Risk Management.
- Excellent communication skills - capacity to communicate regulations to technical functions within the company.
- Demonstrated success in a people management role.
- Ability to work effectively in a strongly matrixed team-oriented structure.
- Excellent interpersonal and relationship management skills.
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.
- A supportive, diverse, and inclusive culture focused on innovation and teamwork.
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