Principal Regulatory Affairs
Principal Regulatory Affairs
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$ 120000 - 150000
1 Vacancy
Job Description
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 youre 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 highperforming team.
Be part of a company thats 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 were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges.
This Principal Regulatory Affairs Specialist for Mammotome is responsible for ensuring bestinclass 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 worldclass Regulatory organizationread 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 costsaving 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 bachelors 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 $120000 to $150000. 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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.
Join our winning team today. Together well accelerate the reallife impact of tomorrows 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 .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race color national origin religion sex age marital status disability veteran status sexual orientation gender identity or other characteristics protected by law. We value diversity and the existence of similarities and differences both visible and not found in our workforce workplace and throughout the markets we serve. Our associates customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
Employment Type
Full-Time
