Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Mammotome, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Mammotome, our expertise and compassion for breast care makes us the indispensable partner to physicians, clinicians and patients. Our drive for developing innovative technology is rivaled only by our compassion for the people we serve, from the clinicians and surgeons who demand consistently precise solutions, to the patients and families seeking peace of mind. When you join our company, you join in the fight against breast cancer. Working at Mammotome means you will have the opportunity to collaborate with a diverse, hardworking, high-performing team committed to improving patient outcomes. As a trusted leader in breast cancer diagnostics, we invite you to join us and support products you can feel passionate about!
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Specialist, Commercial Regulatory Affairs is responsible for navigating complex regulatory landscapes to ensure that our innovative diagnostic solutions meet all necessary regulatory standards, driving significant business impact within the organization.
This position reports to the Senior Manager Commercial Quality & Regulatory Affairs in Korea and is part of the Danaher Diagnostics Global Commercial Quality and Regulatory Affairs team located in Hi Brand Bldg., Seoul, Republic of Korea and will be an on-site role.
In this role, you will have the opportunity to:
+ Lead the preparation and submission of regulatory filings in accordance with the Korea MFDS etc. standards.
+ Collaborate cross-functionally to align regulatory strategies with business objectives.
+ Monitor and interpret evolving regulatory requirements, advising teams on potential impacts.
+ Facilitate communication with regulatory agencies (MFDS, HIRA, and NECA, etc.) to expedite approvals and resolve challenges.
+ Develop and implement Post-Marketing Surveillance (PMS) strategies to ensure ongoing compliance and product safety.
+ Provide strategic guidance to project teams on regulatory pathways and timelines.
The essential requirements of the job include:
+ Bachelor’s degree in scientific discipline or related field.
+ A minimum of over 7~10 years of experience in Regulatory Affairs within the medical device and healthcare industry.
+ Proven proficiency in global and local regulatory systems and requirements.
+ Demonstrated success in managing complex regulatory submissions and interactions.
+ Strong analytical skills with the ability to interpret regulatory guidelines and impacts.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to overseas travel up to 20%, including overnight stays, within designated territories or locations
It would be a plus if you also possess previous experience in:
+ Leading local and global regulatory affairs projects with cross-functional teams.
+ Developing regulatory strategies for various high Class registration tracks in diagnostic product lines .
+ Preferred candidates with prior experience in reimbursement listing and new health technology assessment (nHTA) processes
+ Holding relevant domestic or international Regulatory Affairs certifications.
Mammotome, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .
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 .
