Senior Director, Regulatory Affairs
vor 1 Woche
At Hologic, Inc., we are committed to empowering people to live healthier lives everywhere, every day. As a leading innovator in women's health, we are seeking a highly skilled and experienced Senior Director, Regulatory Affairs to join our team.
Job Summary:The Senior Director, Regulatory Affairs will be responsible for leading our international regulatory affairs team, overseeing regulatory activities for new and mature products in our international markets, and ensuring alignment and compliance with local and regional registration requirements. This role will also involve developing and implementing strategies for timely submissions and approvals of pre-clinical submissions, applications for clinical trials, and marketing applications.
Key Responsibilities:- Lead the development and implementation of global regulatory strategies to influence strategic and operational plans.
- Oversee the preparation and submission of regulatory applications, including pre-clinical submissions, applications for clinical trials, and marketing applications.
- Provide counsel to the Regulatory Affairs team on regulatory requirements and guidelines.
- Collaborate with cross-functional teams, including 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 budgets 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, directing and controlling the activities of one or more functional areas, divisions, product groups, or service areas through senior managers.
- Select, develop, and evaluate personnel to ensure the efficient operation of the function.
- Responsible for the review and approval of regional promotional, advertising, and labeling items.
- Provide counsel, training, and interpretation of global regulations and other regulatory issues to colleagues and assist as a liaison between the Company and regulatory authorities.
- Lead in talent management, succession planning, and employee development to ensure a strong talent pipeline.
- Support compliance to the EU Medical Device Regulation (EU MDR), In-Vitro Diagnostics Regulation (EU IVDR), Canadian Medical Device Regulations, and other global regulations, as applicable.
- 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.
- 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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