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Temp Regulatory Consultant
BrukerSenior Regulatory Affairs Specialist maintaining compliance for NanoString's products, focusing on instrument/software development and manufacturing. Leading regulatory initiatives and managing compliance activities.
About the role
Key responsibilities & impact- 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
- Use excellent time management, verbal and written communications
Requirements
What you’ll need- 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
- Previous in vitro diagnostic (IVD) nucleic acid experience highly preferred
- Certifications: RAC, CQA, CQM preferred
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
Regulatory AffairsFDA QSRISO 13485ISO 9001in vitro diagnostic (IVD)nucleic acid experienceMolecular Biologyregulatory compliancerisk managementregulatory submissions
Soft Skills
time managementverbal communicationwritten communicationinterpersonal skillsorganizational skillsinfluencing skillsability to support multiple projectsintellectual curiosityability to digest complex technical datateam collaboration
Certifications
RACCQACQM