Bachelor’s degree in engineering, Science or related area
Competence with MS office (Excel, PowerPoint, etc.)
Familiarity with SQL, visualization tools (E.g. Tableau, PowerBI)
Excellent interpersonal communication and collaboration skills
proficiency with written English and with neutral English accent

Preferred Qualifications/ Skills
Strong technical knowledge
Hands on experience on Advance excel, VBA, Python, MS Access,
Previous experience in a customer service role chat/email/voice
Effective probing skills and analyzing / understanding skills
Problem solving skills with customer centric approach Demonstrated

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Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations
Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard.
Proficiency in interpreting, applying complex regulations, and preparing associated documentation.
Excellent interpersonal communication and collaboration skills
Bachelor’s degree in engineering, Science or related area
Minimum of 2 years of experience working with medical devices regulations and quality management system.

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Need Locals to Michigan

Must be available for In-person interview

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Top Skills & Years of Experience Required:
• Years of experience: 5 or more years of experience in the field
• Experience with and knowledge of .NET, HTML, XML, SQL, SOAP, REST, PowerShell, IaC, Microsoft Azure, Function Apps.
• Experience writing and implementing Infrastructure as Code (IaC).
• Knowledge of both Microsoft Azure, web-based, and client server-based systems architecture.

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Job description

•       At Least 8+ years experience working with life sciences or healthcare companies performing system implementation experience either as a consultant, business, or IT representative
•       In-depth knowledge of drug development processes and regulatory submissions; including, Labeling, Submission Publishing and/or Viewing systems
•       Proven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction
•       Influential; experience leading teams through hard decisions and negotiating compromises
•       Technical abilities and willingness to “roll up your sleeves” to design and implement a RIM solution
•       Expert on life sciences compliance and computer systems validation requirements
•       Ability to work independently in a dynamic environment
•       Typical travel is 25% but may be up to 50% based on customer requirements

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