Temp Regulatory Consultant

Job not on LinkedIn

🔥 8 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Bruker

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1960

⚕️ Healthcare Insurance

🧘 Wellness

🏢 Enterprise

💰 Post-IPO Debt on 2019-12

Healthcare Insurance • Wellness • Enterprise

Bruker is not just a healthcare provider; it is a partner in well-being and success. Their mission revolves around 'Heal, Live Pain-Free, Thrive,' and they focus on transforming lives through a comprehensive approach to health and wellness. Bruker provides services in physical therapy, mental health, and primary care, aiming to empower individuals and communities to lead healthier lives. They also offer corporate solutions and consulting services to enhance employee health and productivity.

📋 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 • Use excellent time management, verbal and written communications

🎯 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 • Previous in vitro diagnostic (IVD) nucleic acid experience highly preferred • Certifications: RAC, CQA, CQM preferred

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options