Sr. Regulatory Affairs Specialist Core and NGS (USA, REMOTE)

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 group located in Coralville, IA, USA 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: 

• Support a team responsible for worldwide submission activities, maintenance of approvals and global regulatory strategies, across multiple sites, in support of PMA, 510(k), de novo, technical files, pre-submissions, annual renewals, change notifications, post-market surveillance activities, etc. Provide guidance, mentoring, and support to regulatory colleagues with less experience.
• Author and/or review regulatory documents for global market entry, Design History Files, and perform regulatory activities in support of CAPAs, recalls, and medical device reporting to achieve departmental and business objectives.
• Work cross-functionally to provide regulatory expertise, training, and process improvements, and act as core team member on new product development teams. Support internal and external audits.
• Review product marketing materials for accuracy and regulatory compliance. Provide regulatory support and training to the marketing team.
• Other duties as assigned.

The essential requirements of the job include: 

• Minimum bachelor’s degree in a technical field such as chemistry, biochemistry, biology, or related required.
• Minimum 4 years of global regulatory experience related to in vitro diagnostics.
• Knowledge and experience in global IVD regulations, quality standards and product development process such as ISO 13485, US FDA 21 Part 820, IVDR, design control, risk management, etc.
• Experience working in a QMS.
• Experience communicating, training, and negotiating cross-functionally.

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

• Experience in IVD software.
• Experience in the assay development process.

At IDT 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 IDT can provide. 

The salary range for this role is $80,000-$100,000. 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.

We offer a 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. 

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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.

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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