Regulatory Affairs Associate

Job description

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 proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Job Title: Regulatory Affairs Associate

Location: Coralville, IA

Purpose Statement:

The Regulatory Affairs Associate will on work projects, as assigned, to assist in providing regulatory support and guidance across the business to ensure compliance focus.

Job Specific Duties/Essential Functions:

• Work cross-functionally with new product development teams to understand regulatory needs and report to regulatory supervisor to assist in resourcing and scoping for project needs.

• May review product labeling and marketing materials for accuracy and regulatory compliance

• May assess requirements and outline potential options for consideration by regulatory leadership.

• May determine, develop, and provide feedback to approaches on assignments

• May lead projects requiring coordination with other functions and/or third parties

• Proactively seeks regulatory knowledge, staying abreast changing global regulations and asking questions to regulatory leadership that may affect the business.

• Assist in preparation of a variety of regulatory documents such as regulatory submissions, documentation, technical files, letters, communication etc. as assigned

• Demonstrates behavior consistent with the Integrated DNA Technologies Core Values.

• Performs other duties as assigned.

Education, Licensure, Certification, Registration:

• Bachelor's degree in related field required

Professional Experience:

• Experience in quality, clinical, scientific, or other related field preferred.

• Experience in a regulated industry required.

• Experience working in a QMS required; ISO 9001 or ISO 13485 preferred.

Other Knowledge, Skills, and Abilities:

• Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat

• Regulatory, Quality, and/or Scientific experience preferred

• Demonstrate general understanding of technical/scientific principles

• Must be detail oriented and open to learning new concepts

• Strong oral and written communication and presentation skills

Travel Requirements:

• Seldom = Up to 5% of the time

What We Offer:

• Generous Paid Time Off Accruals

• 16 Hours PAID Volunteer Time Off

• 10 Paid Holidays

• Up to eight (8) weeks of 100% paid parental leave to eligible U.S. associates

• 401(k) with Company Match

• Medical, Dental, and Vision Insurance Options

Integrated DNA Technologies (IDT) conducts drug screens and background checks on applicants who accept employment offers.

When you join us, you'll also be joining Danaher's global organization, where 69,000 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 tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation as required by law.

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 to request accommodation.

If you've ever wondered what's within you, there's no better time to find out.