Danaher Corporation Senior Regulatory Affairs Specialist REMOTE in Milwaukee, Wisconsin
Leica Biosystems 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. If you're a Senior RA Specialist passionate about IVD products, we want to hear from you!
Location: This position is eligible for a remote or hybrid work arrangement in which you can work remotely full-time or, part-time at the Richmond, Illinois location and part-time from your home.
The Senior Regulatory Specialist will provide collaborative leadership within the Richmond Regulatory Affairs (RA) team as well as cross-site partnership for project execution. In this position, you will work with cross functional teams to bring IVD (In-Vitro Diagnostic) medical products to market and ensure ongoing compliance while continuing to build your regulatory affairs skills. The Senior Specialist will recommend improvements to standard work for product registrations, listings, and renewals globally. Strong problem solving and decision making skills are essential to drive regulatory compliance efforts.
Responsibilities we will trust you with:
Provide product regulatory strategy and registration guidance for on site NPD and sustaining projects. Identify pathways to market and requirements to sustain regulatory compliance for consumables 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.
When assigned, review and approve Marketing, Advertising, Promotional, Scientific and Sales (MAPSS) materials to ensure compliance with regulations in country/countries where materials are distributed, in accordance with the LBS/Danaher MAPSS policy.
Provide regulatory affairs support during site audits (i.e. MDSAP, GMP, etc.) which includes but is not limited to: preparing product regulatory documentation for review by auditors, be able to communicate product regulatory status and state of adherence to country specific regulatory requirements.
Your areas of knowledge and expertise that matter most for this role:
Education: Bachelor's Degree, preferably in Engineering or Life Sciences.
5+ years-experience within medical device/IVD or pharmaceutical industry; Histology/Pathology experience is a plus.
Strong FDA and Health Canada Class I and Class II regulatory knowledge including registration maintenance, device listings, regulatory requirements, and North America IVD regulatory intelligence.
Experience with ISO 13485:2016, IVD Regulations, FDA GMP and domestic/international Medical Device Regulations.
Experience with support of cross functional new product development
perspective including risk management, review of technical files, product labels/IFU, new product approval and registration.
RAC (Regulatory Affairs Certification) is a plus.
The ability to adapt in an environment of change, uncertainty, and ambiguity. Can pragmatically communicate with the business, make decisions and problem solve in a timely fashion, especially when there is not a clear path.
Mentor or training experience with emerging career RA associates.
What We have to Offer: Leica Biosystems offer competitive pay, benefits and career development. You can learn more at www.DanaherBenefitsInfo.com
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 firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.