Temp Regulatory Consultant

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Bruker

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🧬 Biotechnology

🔬 Science

🔧 Hardware

🔥 Funding within the last year

💰 $582M Post-IPO Equity - Bruker on 2025-09

Biotechnology • Science • Hardware

Bruker is

📋 Description

• Maintain Regulatory Affairs documents, policies, plans and procedures to support compliance with regulatory requirements • Review labeling/promotional/advertising materials, and other documents to ensure regulatory compliance • Represent and/or lead Regulatory affairs in project team meetings throughout the lifecycle of large-scale projects • Assist in the interpretation and submission of domestic and international regulatory registrations, testing and certifications • Assist regulatory initiatives for compliance and risk management • Interpret Regulatory Affairs policies and guidance and correctly apply them as regulatory activities • Manage for the successful execution of regulatory plans • Participate in internal and external Quality and Regulatory audits • Maintain current knowledge of relevant regulations and trends, including proposed and final rules

🎯 Requirements

• BA/BS degree is required • Previous in vitro diagnostic (IVD) nucleic acid experience, a plus • 2-5 years of (hands-on) experience in Regulatory Affairs • Working knowledge of FDA QSR, ISO 13485 and ISO 9001 regulations • Experience in a Molecular Biology research environment, a plus • Excellent interpersonal skills with the ability to influence others in a positive and effective manner • Strong organizational skills and the ability to support multiple projects • Proven ability to work on product development teams • Intellectual curiosity and an ability to digest complex technical data • Preferred education/experience includes bioengineering, biological, physical, clinical and regulatory sciences. • Advanced degrees (MS, MBA, PhD., etc.) a plus • Strong intellectual capacity and curiosity desired • Certifications: RAC, CQA, CQM preferred

🏖️ Benefits

• Health insurance • Professional development