Senior Regulatory Affairs Specialist

3 weeks ago

Cincinnati, United States Mammotome Full time

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 Senior Regulatory Affairs Associate for Mammotome is responsible for ensuring best-in-class compliance through the product lifecycle with a focus on change control, the UKCA marking program, and process development and improvement.

Role Overview (Scope/Focus/Key Responsibilities/Daily Activities/Working with other Depts, etc.)

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

You will be part of the Global Regulatory Affairs team, report to the Director of Regulatory Affairs, and be responsible for lifecycle regulatory activities and certain international registrations. 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 requirements for New Product Development, Sustainability, and cost-saving projects. Provide regulatory input throughout the project's lifecycle to ensure alignment of business needs and regulatory requirements.
  • Manage responses to regulatory agency inquiries.
  • Communicates and negotiates with global regulatory agencies to meet business goals and regulatory achievements for product commercialization.
  • Develop processes and checklists and create procedures to assure early visibility for regulatory requirements related to claims identification and substantiation, labeling promotional materials, and ensuring the validity of regulatory compliance issues.
  • Drives continuous improvement initiatives, solves complex problems and drives results.
The essential requirements of the job include:
  • Understanding global medical device requirements and practical experience in implementing or managing such activities.
  • A successful track record working in a global matrix/collaborative environment is required.
  • The capacity to plan, organize, and complete projects on time. Excellent project management, communication skills, and the ability to manage multiple responsibilities and deadlines.
  • A bachelor's degree with a specialization in a STEM field is preferred.
  • Suggest 8+ years of experience in a regulated industry (pharma, medical 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 $90,000 to $120,000. 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.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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 applyassistance@danaher.com to request accommodation.

  • Clinical Research Specialist in Regulatory Affairs

    2 weeks ago

    Cincinnati, Ohio, United States University of Cincinnati Full time

    Welcome to the University of CincinnatiAre you interested in becoming part of a prestigious institution recognized as a leading urban public research university in the United States? The University of Cincinnati, founded in 1819, provides a dynamic campus environment and a legacy of groundbreaking research.Position OverviewWe are seeking a Clinical Research...

  • Clinical Research Specialist in Regulatory Affairs

    2 weeks ago

    Cincinnati, Ohio, United States University of Cincinnati Full time

    Welcome to the University of CincinnatiAre you interested in becoming part of a leading urban public research university in the United States? The University of Cincinnati, founded in 1819, boasts a dynamic campus environment and a legacy of groundbreaking research.Position OverviewWe are seeking a Clinical Research Professional to assist with regulatory...

  • Clinical Research Specialist in Regulatory Affairs

    2 weeks ago

    Cincinnati, Ohio, United States University of Cincinnati Full time

    Welcome to the University of CincinnatiAre you interested in becoming part of a prestigious institution recognized as one of the leading urban public research universities in the United States? The University of Cincinnati, founded in 1819, provides a dynamic campus environment and a legacy of innovation.Position OverviewWe are seeking a Clinical Research...

  • Regulatory Specialist

    1 month ago

    Cincinnati, United States Ditsch Full time

    Job DescriptionJob DescriptionRole: Regulatory SpecialistReport to: Senior Quality & Food Safety ManagerAnnual Salary: $60,000 to $75,000Shift hours: N/ALocation: Ditsch Springfield, Ohio 45246Regulatory Specialist - Ensuring Compliance to Food Safety StandardsWe are looking for a Regulatory Specialist to join our team and help us maintain our high standards...

  • Junior Regulatory Specialist

    6 days ago

    Cincinnati, United States Zing! Recruiting Full time

    Job DescriptionJob DescriptionWe are seeking a detail-oriented and proactive Junior Regulatory Specialist to join our team. This position is ideal for individuals with a passion for regulatory affairs and a background in the food and beverage industry. The successful candidate will work under supervision to ensure that product information and technical...

  • Junior Regulatory Specialist

    6 days ago

    Cincinnati, United States Zing Recruiting Full time

    Job DescriptionJob DescriptionWe are seeking a detail-oriented and proactive Junior Regulatory Specialist to join our team. This position is ideal for individuals with a passion for regulatory affairs and a background in the food and beverage industry. The successful candidate will work under supervision to ensure that product information and technical...

  • Regulatory Affairs Manager

    5 days ago

    Cincinnati, Ohio, United States Clean Harbors Full time

    Job SummaryClean Harbors is seeking a highly skilled Environmental Compliance Specialist to manage day-to-day regulatory functions at our operating facilities. As a key member of our team, you will be responsible for ensuring compliance with federal, state, and local regulations, as well as maintaining a safe and healthy work environment.Key...

  • Regulatory Affairs Manager

    5 days ago

    Cincinnati, Ohio, United States Clean Harbors Full time

    Job Summary:Clean Harbors is seeking an experienced Environmental Compliance Specialist to manage day-to-day regulatory functions at our operating facilities. As a key member of our team, you will be responsible for ensuring compliance with federal, state, and local regulations, as well as maintaining a safe and healthy work environment.Key...

  • Senior Regulatory Affairs Consultant

    2 weeks ago

    Cincinnati, Ohio, United States TEPHRA Full time

    Position Overview:The selected candidate will collaborate with clients and internal teams to provide top-tier solutions for regulatory submissions. Support the development of technical documentation (including technical files and design dossiers) for Spine products, ensuring compliance with the new Medical Device Regulation (MDR) in the European Union.Key...

  • Quality Assurance Regulatory Consultant

    1 week ago

    Cincinnati, Ohio, United States Ditsch Full time

    Job OverviewPosition: Regulatory SpecialistReporting to: Senior Quality & Food Safety ManagerSalary Range: $60,000 to $75,000Work Schedule: N/ALocation: Ditsch Springfield, Ohio 45246Role Summary: Ensuring Adherence to Food Safety RegulationsWe are seeking a dedicated Regulatory Specialist to become a vital part of our team, committed to upholding our...

  • Environmental Compliance Specialist

    5 days ago

    Cincinnati, Ohio, United States Clean Harbors Full time

    Job SummaryWe are seeking a highly skilled Environmental Compliance Specialist to join our team at Clean Harbors. As a key member of our operations team, you will be responsible for ensuring compliance with federal, state, and local regulations related to environmental affairs and health and safety.Key ResponsibilitiesRegulatory Compliance: Conduct formal...

  • Food Safety Regulatory Analyst

    2 weeks ago

    Cincinnati, Ohio, United States Ditsch Full time

    Job OverviewPosition: Regulatory SpecialistReporting To: Senior Quality & Food Safety ManagerSalary Range: $60,000 to $75,000Work Schedule: N/ALocation: Ditsch Springfield, Ohio 45246Role Summary: Ensuring Adherence to Food Safety RegulationsWe are seeking a dedicated Regulatory Specialist to become a vital part of our team, committed to upholding our...

  • Compliance Specialist

    3 days ago

    Cincinnati, Ohio, United States Western & Southern Financial Group Full time

    Job SummaryWe are seeking a highly skilled Compliance Specialist to join our team at Western & Southern Financial Group. As a Compliance Specialist, you will play a critical role in ensuring that our company meets all insurance and federal regulatory compliance requirements.Key ResponsibilitiesConduct regular monitoring and oversight to identify and...

  • Emergency Medical Transportation Specialist

    2 weeks ago

    Cincinnati, Ohio, United States Veterans Affairs, Veterans Health Administration Full time

    Position OverviewThe Emergency Medical Transportation Specialist is a critical role within the Veterans Affairs, Veterans Health Administration. This position is integral to the Veterans Transportation Services, providing essential support in emergency medical situations.Key ResponsibilitiesPerform all essential duties of a Paramedic and Emergency Medical...

  • Emergency Medical Transportation Specialist

    2 weeks ago

    Cincinnati, Ohio, United States Veterans Affairs, Veterans Health Administration Full time

    Position OverviewThis role as an Emergency Medical Transportation Specialist is integral to the Veterans Affairs, Veterans Health Administration. The position is focused on providing essential transportation services to veterans requiring medical attention, ensuring that they receive timely and effective care during emergencies.Key ResponsibilitiesThe...

  • Emergency Medical Transport Specialist

    2 weeks ago

    Cincinnati, Ohio, United States Veterans Affairs, Veterans Health Administration Full time

    Position OverviewThis role as an Emergency Medical Transport Specialist is integral to the Veterans Affairs, Veterans Health Administration. You will be part of the Veterans Transportation Services, operating within various medical facilities that provide emergency and urgent care.Key ResponsibilitiesThe primary responsibilities encompass:Performing all...

  • Senior Care Coordinator

    5 days ago

    Cincinnati, Ohio, United States Senior Lifestyle Full time

    Job SummaryWe are seeking a skilled and compassionate Registered Nurse to join our team at Senior Lifestyle. As a Nurse Care Specialist, you will play a vital role in providing high-quality care to our residents and ensuring their overall well-being.Key ResponsibilitiesSupervise and administer medications in compliance with Federal and State regulations, as...

  • Wound Care Sales Specialists

    3 months ago

    Cincinnati, United States Barrington James Full time

    Sales Representatives – Wound Care Specialist Southern Ohio RegionFTE - 1099 Barrington James Recruitment has partnered with a fantastic biotechnology firm that specializes in advanced wound care. They develop and market innovative solutions for chronic wounds, and surgical wounds. The portfolio comprises topical treatments and the company is committed to...

  • Wound Care Sales Specialists

    3 months ago

    Cincinnati, United States Barrington James Full time

    Sales Representatives – Wound Care Specialist Southern Ohio RegionFTE - 1099 Barrington James Recruitment has partnered with a fantastic biotechnology firm that specializes in advanced wound care. They develop and market innovative solutions for chronic wounds, and surgical wounds. The portfolio comprises topical treatments and the company is committed to...

  • Regulatory Compliance Specialist

    2 weeks ago

    Cincinnati, Ohio, United States TEPHRA Full time

    Position Overview:The selected candidate will collaborate with clients and internal teams to provide exceptional solutions for regulatory submissions. Support the development of technical documentation (including technical files and design dossiers) for Spine products that comply with the new Medical Device Regulation (MDR) in the European Union.Key...