As the Regulatory Affairs Director, you will lead the AI and Connected Health franchise for Regulatory and be a member of the Franchise Lead Team. As the Director, Regulatory Affairs, you will guide all regulatory activities for both new and existing products, ensuring full alignment and compliance with local and regional registration requirements, as well as with company policies.
This pivotal role involves developing and implementing strategic plans for the timely submission and approval of pre-clinical submissions, clinical trial applications, marketing authorizations, and more. You will provide expert counsel and leadership to the regulatory team, ensuring the preparation of well-organized and scientifically robust applications. Apply today !
What You Will Do
Partners with divisional leadership to develop and meet organizational goals while supplying technical expertise and guidance on projects, operations, and systems. Responsible for communicating the purpose, direction and strategic importance of organizational goals, setting expectations, developing metrics to measure team performance and implementing strategies to meet project and departmental objectives. Responsible for recruiting, retaining, and managing multiple direct reports including managers and/or supervisors. Responsible for planning, assigning, and directing work, performance management, facilitating employee development, mentoring and coaching to maximize engagement and productivity. Oversees regulatory strategies and relationships for market access and business continuity, establishing collaborative relationships with stakeholders and advocacy groups globally. Manages and monitors the development and implementation of regulatory affairs programs and strategies for BSH ensuring compliance with applicable regulations (FDA, MDD and EU MDR and other internal requirements) while aligning with business objectives.
What You Will Need
Proven track record of successful regulatory submissions and approvals for AI-driven medical technologies. Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, MDD/MDR regulations and relevant global regulations related to medical devices. Strong knowledge in medical device Design Controls, Risk Management and Cybersecurity requirements. Previous experience in advocacy and policy efforts preferred such as involvement with AdvaMed working groups. Computer literate; able to use word processing, spreadsheet programs, databases. Excellent ability to read, analyze and interpret professional journals, technical procedures, and government regulations. Strong ability to effectively present information and respond to questions from senior management, function heads, managers, supervisors, and all levels of employees. Excellent interpersonal skills to interact with all levels of the company, sometimes in an adversary role. Demonstrated success in management role. Ability to work effectively in a strongly matrixed team-oriented structure. Excellent communication, interpersonal and relationship management skills Experience in medical device, pharmaceutical or equivalent regulated industry QA and/or RA certification is beneficial.
Qualifications:
Education
Preferred Minimum Non-Technical Degree: BA/BS Degree Preferred Minimum Technical/Advanced Degree: Master’s Degree
Experience
Preferred Minimum Non-Technical Degree: 12 + Years Preferred Minimum Technical/Advanced Degree: 10 + Years with Master’s Degree, 8 + Years with PhD
So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!
The annualized base salary range for this role is $158,900 - $282,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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