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.

You will become a member of the Global Regulatory Team and participate in global regulatory activities, including regulatory submissions, renewals, license inventory, product and process change assessments, labeling review and general regulatory documentation requests. Participate on New Product Development (NPD) teams to develop and execute a regulatory strategy for new product launches.

At OPCO 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 OPCO can provide.

Responsibilities

• Lead the preparation of regulatory submission documentation

• Work with project teams 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

• Provide regulatory support for internal and external (Regulatory Agency) audits and assist with resolving observations

• Manage facility licensing activities (e.g., Establishment Registrations, Product Listings, Export Certificates (Certificates to Foreign Governments [CFGs])

• Identify specific changes in global regulations, develop strategies for compliance and provide updates of upcoming changes

• Evaluate and implement procedures pertaining to corporate and departmental regulatory activities

Qualifications

• Bachelor’s degree in Science/Technology, Mechanical/Biomedical Engineering, a clinical field or equivalent

• 5+ years of Regulatory, Clinical or Engineering experience in the food, drug or device industry

• Understanding of global medical device requirements and practical experience in implementing or managing such activities

• Successful track record working in a global matrix/collaborative environment

• Software system familiarity, including Learning Management Systems, Document Management Systems and Microsoft Office Suite

Preferred Qualifications

• Oncology experience

• Professional certifications such as CQM/OA, RAB or RAPS

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When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.