Streck
Manufacturing
RegulatoryAffairsManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Regulatory Affairs Manager at Streck. Skills: Regulatory affairs, FDA regulations, International regulations, Compliance. Develop and implement regulatory strategies. Prepare and submit regulatory filings”
Industry & Context.
Problem solving; Analytical skills
What They're Looking For.
Must Have
Bachelor's degree in a scientific discipline, 5+ years of regulatory affairs experience, Experience with FDA regulations, Experience with international regulations
Nice to Have
Master's degree or PhD, Experience with medical devices, Experience with combination products
What You'll Do.
Develop and implement regulatory strategies
Prepare and submit regulatory filings
Ensure compliance with regulations
Monitor regulatory changes
Provide regulatory guidance
Manage regulatory projects
Liaise with regulatory agencies
Assess regulatory risks
How You'll Work.
Team & Collaboration
Cross-functional teams; Research and Development; Quality Assurance; Legal department
Communication Scope
Regulatory communication; Report writing
Process & Methodology
Project management
Full Job Description
## Description About Streck: Streck is a Nebraska-based manufacturing company that makes a global impact by developing and distributing to labs worldwide. Our products provide confidence for accurate health care testing! Our passions and priorities are focused on taking care of our customers, employees, and giving back to our community. Streck has jobs for every stage of your career. If you are a dependable, hard-working, and team-oriented individual who values meaningful work, Streck is looking for you to join our community of passionate people on a mission! ## Streck Offerings A challenging, safe and rewarding work environment No night or weekend shifts Excellent work life balance Market competitive pay Comprehensive and inclusive benefits Great team environment On and off campus career development opportunities ## Additional Information Visit www.streckcareers.com to learn more about Streck and apply for this opportunity. Streck is an Equal Employment Opportunity Employer/Individuals with Disabilities & Protected Veterans/Affirmative Action employer and forbids discrimination against any employee or applicant because of race, color, religion, gender (including pregnancy, gender stereotyping and caregiver status), sexual orientation, gender identity, transgender status, national origin, disability, genetic information, citizenship, marital status or status as a covered veteran in accordance with applicable federal, state and local laws.
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