Principal, RA Specialist

<div><div><p><b><span>Bring more to life.</span></b><span> </span></p></div><div><p><span> </span></p></div><div><p><span><span>Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? </span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><span><span>At<span> </span></span><span>Integrated DNA Technologies (IDT),</span><span><span> </span>one of<span> </span></span></span><a href="https://danaher.com/our-businesses" target="_blank" rel="noopener noreferrer"><u><span>Danaher’s</span></u></a><span><span><span> </span>15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.  </span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><span><span>You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And<span> </span></span><span>by harnessing<span> </span></span><span>Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.</span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><span><span>Our team at Integrated DNA Technologies (IDT), is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more. At IDT, you’ll be part of a culture rooted in continuous learning and improvement—where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all.</span></span><span> </span></p></div><div><p><span><span>Learn about the<span> </span></span></span><a href="https://www.danaher.com/how-we-work/danaher-business-system" target="_blank" rel="noopener noreferrer"><u><span>Danaher Business Syste</span></u><u><span>m</span></u></a><span><span><span> </span>which makes everything possible.</span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><span><span>The</span><span><span> </span></span><span>Principal Regulatory Affairs Specialist<span> </span></span><span>is responsible</span></span><span><span><span> </span>fo</span><span>r developing and executing strategies for global market introduction of new and modified IVD medical devices and software while acting as a SME within the Global Regulatory team and providing mentorship to entry-l</span><span>evel and intermediate associates. </span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><span><span>This position<span> </span></span><span>reports to the</span><span><span> </span>Manager, Regulatory Affairs<span> </span></span><span>and<span> </span></span><span>is part of the</span><span><span> </span>Regulatory Affairs team</span><span><span> </span></span><span>l</span><span>ocated in</span><span><span> </span>Boulder, CO</span></span><i><span><span> </span></span></i><span><span>and will be</span><span><span> </span></span><span>fully remote</span><span>.  </span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><b><span>In this role, you will have the opportunity to:</span></b><span> </span></p></div><div><ul><li><p><span><span>Author and lead the creation of regulatory documents (regulatory submissions/filings, registration and listing, technical files, etc.) to obtain global approvals to commercially distribute products; collaborates with international colleagues in global regions to submit <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">application/registration</span> documents. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Provide guidance and approve regulatory/quality documentation related to new product development deliverables acting as core team member conducting regulatory assessments related to design changes, advising and approving protocols, reports, marketing material, etc. <span> </span></span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Assess risk levels associated with current and emerging regulatory issues, providing guidance to facilitate and ensure practices are consistent with the corporate guidance and<span> </span></span><span>SOPs; interpret new and/or existing regulatory requirements ensuring compliance with applicable agency requirements, published standards, local procedures and project specific plans. </span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div></div><div><div><p><b><span>The essential requirements of the job include</span><span>:</span></b><span> </span></p></div><div><p><u><span>Education, Licensure, Certification, Registration </span></u><span> </span></p></div><div><ul><li><p><span><span>Bachelor’s degree in a technical field such as chemistry, biochemistry, biology, or related</span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><u><span>Professional Experience:</span></u><span> </span></p></div><div><ul><li><p><span><span>Minimum 7 years of experience in regulated environment required; 4+ years of global regulatory experience related to<span> </span></span></span><i><span>in vitro diagnostics</span></i><span><span><span> </span>required. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Knowledge and experience in U.S. FDA and EU IVD regulations; with proven experience in submission of PMA, de novo, 510(k) and/or technical files <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">required.  </span></span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Experience and understanding of product development process inclusive of Design Control and Risk Management; broad knowledge and previous application of ISO 13485, IVDR, and 21 CFR Part 820 required. </span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><b><span>It would be a plus if you also possess previous experience in:</span></b><span> </span></p></div><div><ul><li><p><span><span>Strong collaborative facilitation skills with the ability to build consensus while championing global regulatory compliance.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ability to work independently utilizing developed research and analytical skills to manage multiple projects. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Must be a strong collaborative facilitator and leader, building consensus while championing global regulatory compliance</span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><span> </span></p></div><div><p><span><span>IDT</span><span>,</span><span><span> </span></span></span><span><span>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</span><span><span> </span></span></span><a href="https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home" target="_blank" rel="noopener noreferrer"><u><span>Danaher Benefits Info</span></u></a><span><span>.</span></span><span> </span></p></div><div><p><span><span>At<span> </span></span></span><span><span>IDT</span></span><span><span><span> </span></span><span>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<span> </span></span></span><span><span>IDT</span></span><span><span><span> </span></span><span>can provide.</span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><span><span>The<span> </span></span><span>annual<span> </span></span><span>salary range for this role is</span><span><span> </span>$110</span><span>,000<span> </span></span><span>-$135</span><span>,000</span></span><i><span>.</span></i><span><span><span> </span>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. </span></span><span> </span></p></div></div><div><p><span><span>This job is also eligible for bonus/incentive pay.</span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><span><span>We offer comprehensive package of benefits including paid time off, <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">medical/dental/vision</span> insurance and 401(k) to eligible employees.</span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><span><span>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.</span></span><span> </span></p><p></p><p>#LI-LCS</p></div><p>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. </p><br><p>For more information, visit <a href="http://www.danaher.com/" target="_blank" rel="noopener noreferrer">www.danaher.com</a>. </p><br><p>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. </p><br><p>The U.S. EEO posters are available <a href="http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf" target="_blank" rel="noopener noreferrer">here</a>.</p><br><p>For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click <a href="https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc" target="_blank" rel="noopener noreferrer"><span style="color:#0875e1"><u>here</u></span></a>.</p><br><p>We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">contact:1-202-419-7762</span> or <a href="mailto:applyassistance@danaher.com" target="_blank" rel="noopener noreferrer"><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">applyassistance@danaher.com</span></a>.</p>

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...