Danaher Corporation Staff Regulatory Affairs Specialist in Waukesha, Wisconsin
Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.
Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.
Leica Biosystems 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.
The Staff Regulatory Affairs Specialist is expected to provide collaborative leadership within the Richmond Quality Assurance & Regulatory Compliance team as well as within the Richmond organization and global LBS teams as required. The Specialist will work with cross functional teams to bring IVD (In-Vitro Diagnostic), medical and chemical products to market and ensure ongoing compliance while continuing to develop regulatory affairs skills.
This role will lead major regulatory efforts requiring cross-site partnership and execution. The Staff Regulatory Compliance Specialist will conduct improvements to standard work for product registrations, listings, and renewals globally.
The Staff Regulatory Compliance Specialist will drive the Danaher Business Systems (DBS) mindset to improve quality, processes, and innovation by applying tools and continuous improvement mind-set.
Provide product regulatory strategy and registration guidance on New Product Development, Design Change and Sustaining projects.
Identify pathways to market and requirements to sustain regulatory compliance for chemical products, IVD products and instrumentation.
Prepare, review, and approve regulatory documentation for submission, including but not limited to Technical Files/Device Files and DoCs, to regulatory agencies or to commercial partners, advise on the submission strategy.
Identify relevant guidance documents, or consensus standards and provide interpretive assistance.
Review and approve Marketing, Advertising, Promotional and Scientific Materials to ensure compliance with regulations in country/countries where materials are distributed.
Provide subject matter expertise during internal and external site audits (i.e. MDSAP, GMP, etc.)
Required Education, Experience, Skills
Education: Bachelor's Degree, preferably in Engineering or Life Sciences.
8+ years-experience within medical device/IVD; Histology/Pathology experience is a plus.
FDA (Class I & II) and Health Canada regulatory knowledge including registration maintenance, device listings, regulatory requirements, and North America IVD regulatory intelligence.
Knowledge of chemical compliance regulations (i.e.: RoHS, TSCA, REACH etc.).
Experience with ISO 13485:2016, IVD Regulations, FDA GMP, and domestic/international Medical Device Regulations.
Experience with support of cross functional new product development from a RA perspective including risk management, review of technical files, product labels/IFU, new product approval and registration.
RAC (Regulatory Affairs Certification) is a plus.
Equal Pay Act
The salary range for this role is $105,000 - $125,000 annually . 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.
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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
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 (https://www.dol.gov/agencies/ofccp/posters) .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 email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.