Be the voice of change in our growing team!
As a Senior Regulatory Affairs (RA) Specialist you will work with cross functional teams to bring medical products to the market and ensure ongoing compliance while continuing to develop their regulatory affairs skills. You will facilitate product registrations, listings and renewals globally, work with project teams to develop and implement regulatory strategy and product regulatory requirements, and develop and maintain global regulatory files, including EU technical files. This role will support the implementation of emerging and new regulatory requirements, including IVDR and the regulatory processes and infrastructure to enable ongoing compliance and may lead cross functional workstreams targeting specific elements of compliance. Ability to recognize and resolve complex challenges potentially impacting compliance with excellent communication skills. Shares information and experience across business unit, LBS and Danaher and may serve as representative on specific task forces, councils, or improvement initiatives.
How will you be successful?
Support product and project managers as well as wider organization to meet product
Handle regulatory requirements for product registrations to support product launches.
Identify relevant guidance documents, or consensus standards and provide interpretive assistance.
Review and approval of documentation and labeling to ensure regulatory compliance
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
Write or update standard operating procedures to ensure that they reflect current regulatory requirements.
Create and maintain technical files
Use Danaher Business System (DBS) tools on a regular basis to continually improve the RA effectiveness and performance establishing and maintaining sustainable metrics.
Working effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
Conduct technical training sessions for colleagues.
Other duties as assigned by management
Bachelor's Degree in Engineering or Life Sciences
3-5 years-experience in RA within medical device, IVD, or pharmaceutical industry
Experience with ISO 13485:2016, global IVD Regulations, FDA GMP and global Medical Device
Knowledge, Skills, Abilities:
Ability to apply practical QA experience and knowledge to one or more area(s) of quality assurance.
Experience with support of cross functional new product development from RA perspective including risk management, review of technical files, new product approval and registration
Ability to effectively communicate to all levels within the organization and influence change outside of the local span of control
Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page
Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.