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Danaher Corporation Sr. Principal, Regulatory Affairs Specialist, Core and NGS in Coralville, Iowa

Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.

IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

This position is part of the Quality Assurance and Regulatory Affairs department in the United States of America and will be remote. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things

In this role, you will have the opportunity to:

  • 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 application/registration documents.

  • Lead execution, 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.

  • Ability to assess risk levels associated with current and emerging regulatory issues, providing guidance to facilitate and ensure practices are consistent with the corporate guidance and SOPs; interprets new and/or existing regulatory requirements ensuring compliance with applicable agency requirements, published standards, local procedures and project specific plans.

  • Lead agency communications and medical device reporting activities, including post-market surveillance, adverse events, and field actions; act as company representative point of contact to negotiate and effectively communicate.

  • Other accountabilities as assigned

The essential requirements of the job include:

  • Bachelor’s degree in a technical field such as chemistry, biochemistry, biology, or related field required.

  • Minimum 10 years of experience in regulated environment required; 8+ years of global regulatory experience related to in vitro diagnostics required.

  • 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 required.

  • 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.

It would be a plus if you also possess previous experience in:

  • Advanced degree in technical field such as chemistry or biochemistry preferred

  • Strong collaborative facilitation skills with the ability to build consensus while championing global regulatory compliance.

  • Ability to work independently utilizing developed research and analytical skills to manage multiple projects.

At IDT we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for IDT can provide.

The salary range for this role is $135,000.00 - $150,000.00. 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 a comprehensive package of benefits including paid time off, medical/dental/vision insurance and Retirement Benefits 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.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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 applyassistance@danaher.com to request accommodation.

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