Bruker logo
Bruker

We offer high-performance scientific instruments and high-value analytical and diagnostic solutions.

Temp Regulatory Consultant

ComplianceComplianceFull TimeRemoteMid LevelTeam 5,001-10,000Since 1960H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

2 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglish

Job Description

Temp Regulatory Consultant

Bruker

• 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

Job 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

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