Principal, Regulatory Affairs

Mammotome associates know that every moment matters when it comes to advancing breast cancer diagnostics and surgical solutions. When you come to work at Mammotome, you’re collaborating with a global team of engineers, designers, communicators, strategists, and specialists to improve patient outcomes. If you want to be inspired to grow every day, join our diverse, hardworking, high-performing team.

Be part of a company that’s a trusted leader in breast cancer diagnostics and support products you can feel passionate about!

Mammotome is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

This Principal Regulatory Affairs Specialist for Mammotome is responsible for ensuring best-in-class compliance through the product lifecycle with a focus on European and International Regulation and process development and improvement.

This position is part of the Regulatory Affairs Department located in Cincinnati, OH, USA and will be fully remote. At Mammotome, our passion is driving innovative technologies that create efficiencies, while never forgetting that at the heart of every breast cancer journey is a patient.

You will be a part of the Global Regulatory Affairs team and report to the Director of Regulatory Affairs and responsible for the UKCA program, Swiss registration program, components of the Mammotome EU MDR program, certain international registrations, change control, and other tasks as assigned. If you thrive in a multifunctional role and want to work to build a world-class Regulatory organization—read on.

In this role, you will have the opportunity to:

• Be the lead RA representative driving certain international requirements for New Product Development, Sustaining, and cost-saving projects to ensure alignment of business needs and regulatory requirements by providing regulatory input through the lifecycle of the project.
• Manage responses to regulatory agency inquires.
• Communicate and negotiate with global regulatory agencies to meet business goals and regulatory achievements for product commercialization.
• Develop processes and checklists and creates procedures to assure early visibility for regulatory requirements related to claims identification and substantiation, labeling promotional materials, and assuring the validity of regulatory compliance issues.
• Drive continuous improvement initiatives, solve complex problems, and drive results.

The essential requirements of the job include:

• Understanding of global medical device requirements and practical experience in implementing or managing such activities, especially related to the European Medical Device Regulation and select additional international requirements.
• Excellent communication skills and successful track record working independently in a global matrix/collaborative environment required.
• The capacity to plan, organize, & complete projects on time. Excellent project management skills and ability to juggle multiple responsibilities and deadlines.
• A bachelor’s degree, specialization in a STEM field preferred.
• Suggest 8 years of experience in regulated industry (pharma, med device, etc.)

It would be a plus if you also possess previous experience in:

• RAC preferred

At Mammotome we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Mammotome can provide.

The salary range for this role is $120,000 to $150,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.