Senior Director, Regulatory Affairs Lead
vor 3 Wochen
Hologic, Inc. is a leading innovator in women's health, empowering people to live healthier lives everywhere, every day.
Our global regulatory affairs team plays a critical role in ensuring compliance with local and regional registration requirements as well as company policies.
As our Senior Director, Regulatory Affairs, you will oversee international regulatory activities for new and mature products in our international markets, ensuring alignment and compliance with local and regional registration requirements, and company policies.
Key Responsibilities:
- Hold accountability for the success of International Regulatory Affairs, working with divisional partners and international leadership to develop and meet organizational goals, while supplying expertise and guidance.
- Partner with Hologic design centers and legal manufacturers, ensuring the 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.
- 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, directing and controlling 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.
Requirements:
- 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.
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