Senior Director, Regulatory Affairs

As a leading innovator of womens' health, we at Hologic are empowering people to live healthier lives everywhere, every day,

Our regulatory affairs team is responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs to influence strategic and operational plans.

As our Senior Director, Regulatory Affairs, you will hold responsibility for our international, oversees and directs regulatory activities for new and mature products in our international markets (outside of the US) to ensure alignment and compliance with local and regional registration requirements as well as with company policies.

You will develop and implement strategies for timely submissions and approvals of pre-clinical submissions, applications for clinical trials, and marketing applications.

Providing counsel to your Regulatory Affairs team, your expertise in both indirect and direct markets in Europe, Middle East, Africa, Asia Pacific, Latin America, and Canada will ensure international alignment and success.

Your ability to operate in a highly matrixed organisation, managing both functional and regional priorities, will enable your success.

What to Expect :

• Hold accountability for the success of International Regulatory Affairs, working with divisional partners and international leadership to develop and meet organizational goals, whilst supplying expertise and guidance.
• Partner with Hologic design centers and legal manufacturers, ensuring the timely preparation of organized and scientifically valid applications.
• Assesses 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.
• Responsibility for designated Economic Operator (or equivalent) responsibilities in the EU and other countries where applicable.
• Provide direction to senior management in various areas, groups, and / or operations.
• Operate as an influential leader. Direct and control the activities of one or more functional areas, divisions, product groups or service areas through senior managers who have overall responsibility for the successful operation of those assigned areas.
• 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.

What We Expect

• Preferred Minimum Technical / Advanced Degree : Bachelor’s degree in science or legal
• 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.

Ready to join a company where your work will help shape the future of women’s health?