Danaher Corporation Regulatory Affairs Specialist II in Coralville, Iowa
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 Specialist II
Location: Coralville, IA Mobile/Remote (On-Site/Work from Home Hybrid)
-Mobile associates must live in an area that does not exceed a 100-mile (150 km) radius of an IDT location. *May require on-site occasional presence for team meetings, etc.
The Regulatory Affairs Specialist II will work on and lead assigned projects to assist in providing regulatory guidance with a quality and compliant culture mindset across the business.
Job Specific Essential Functions:
Responsible for regulatory project timelines and management of global regulatory deliverables as assigned.
Work cross-functionally with new product development teams to provide guidance on regulatory strategy, various global requirements and responding to customer and/or authority inquiries dealing with regulation and compliance.
Review product labeling and marketing materials for accuracy and regulatory compliance.
Support site Quality Management Systems (QMS) – ISO 9001 and ISO 13485
Support internal and external departments to generate, review and approve protocols/reports.
Provide training in areas of regulatory compliance to cross-functional groups
May lead projects requiring coordination with other functions and/or third parties
Proactively manages the changing regulatory environment for company products and assist in eliminating duplication of effort by identifying and providing mitigations to areas of risk.
Assist in preparation of global regulatory submissions, documentation, technical files, etc.
Perform regulatory activities in support of CAPAs, recalls; collaborate cross-functionally supporting evaluation of product complaints and regulatory determinations.
Acts as resource to other colleagues with less experience
Uses best practices and knowledge of internal or external business issues to improve products or services
Explains difficult or sensitive information
Solves complex problems (with coaching); takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information
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
Compliance and/or Research Certifications preferred
Three to five years of professional experience in regulatory or compliance function required
Five or more years in a regulated industry function required
IVD experience preferred, medical device experience required.
Other Knowledge, Skills, and Abilities:
Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
Regulatory, Quality, and/or Scientific experience
Demonstrate general understanding of technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
Must be detail oriented with well-developed organizational and analytical skills
Experiences in experiment design and assay development process is highly preferred
Strong oral and written communication and presentation skills
Experience working in clinical and/or investigational environment preferred (IRB, IND, IDE, CTA, Monitoring, GCP, etc)
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 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 email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.
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