Senior Manager, Regulatory Affairs

Senior Manager Regulatory Affairs

At Endomag a Hologic company we are driven by a clear purpose: advancing health through innovative medical technologies that improve and save lives. We are seeking an experienced Senior Manager Regulatory Affairs to lead the Regulatory function at our Cambridge site.

In this leadership role you will oversee regulatory activities across a portfolio of innovative and established products. You will guide regulatory strategy lead a highperforming team and partner with global and crossfunctional stakeholders to support product development market access and regulatory compliance.

What To Expect:

• Lead the Regulatory Affairs function at the Cambridge site and provide direction to the local regulatory team.
• Develop and execute regulatory strategies for new product development and existing products aligned with global regulatory requirements and company policies.
• Drive regulatory submissions including preclinical submissions clinical trial applications and marketing authorizations to support timely approvals.
• Provide strategic regulatory guidance to crossfunctional teams and translate regulatory requirements into practical development plans.
• Partner with divisional and senior leadership to align regulatory priorities with business and product development goals.
• Build and maintain relationships with regulatory authorities and represent the company in submissions audits and regulatory discussions.
• Support New Product Development programs ensuring regulatory considerations are integrated throughout the product lifecycle.
• Oversee regulatory compliance for marketed products and support lifecycle management activities.
• Ensure product development and design changes comply with FDA Quality System Regulation ISO 13485 and other applicable standards.
• Support regulatory aspects of clinical studies required for regulatory approvals.
• Mentor and develop regulatory team members while managing regulatory priorities timelines and resources.
• Monitor regulatory developments and industry trends to inform regulatory strategy.

What We Expect:

• Degree in engineering or a scientific discipline; biomedical engineering preferred.
• Significant Regulatory Affairs experience within the medical device or similarly regulated industry.
• Proven success managing regulatory submissions and compliance for medical devices; experience with combination products is advantageous.
• Experience interacting with regulatory authorities and supporting approvals in the US and EU.
• Strong knowledge of FDA regulations (21 CFR) ISO 13485 EU MDD/MDR and global medical device regulatory frameworks.
• Solid understanding of medical device Design Controls and Risk Management.
• Demonstrated leadership experience in a matrixed organization.
• Strong analytical communication and stakeholder management skills.
• Ability to manage multiple priorities in a fastpaced collaborative environment.

Why Join Hologic

• Make a Difference:Impact millions of lives by ensuring the highest standards in womens health.
• Grow Your Career:Thrive in a global innovative and supportive environment.
• Drive Change:Be part of a company that values your ideas expertise and leadership.

Ready to make your mark Apply now to lead regulatory excellence at Hologic!

#LI-RH1