Senior Director, Regulatory Affairs Lead

Vor 3 Tagen


Oberwil b Zug, Zug, Schweiz Hologic Vollzeit
Job Summary

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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