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Medical Device Consultant

Rockville, MD 20852

Posted: 02/22/2024 Job Types: Permanent Industry: Medical Device Consultant Job Number: 100956 Pay Rate: $110,000-$140,000

Job Description

Selective Staffing Solutions has partnered with an international group that is a certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle. They strive to deliver the highest expertise within the Lifesciences space and ensure patients’safety. They are looking to add a Medical Device Consultant to their join their growing team in Buffalo, NY!
Summary: The consultant shall participate in the execution and coordination of compliance projects in Medical Device area, bring new expertise in quality management and regulatory affairs for Medical Device, provide guidance to the technical team.
Job Responsibilities:
  • Provide technical oversight of local and global MD compliance and regulatory projects 
  • Tutorship of junior resources and coordination of MD projects execution.
  • Ensure effective Project Management during the activities execution including planning, monitoring and reporting
  • Grant projects governance with focus on time lines and budget control
  • Follow-up and coordinate with MD Management
  • Support clients in projects related to US FDA Regulatory, Quality 21 CFR Part 820 and Clinical Study Design
  • Support the Business Development teams to create and nurture new business relationships with Medical Device Companies in and out of the US

Job Requirements

Job Requirements:
  • 5-10 years of previous experience in similar roles in the Medical Device field with broad spectrum of expertise in Quality Assurance/ Regulatory Affairs of MD industry
  • Knowledge of the MD local regulations
  • Understanding of Quality Management System requirements, risk management principles, regulatory requirements and, industry best practices:
    • 21 CFR part 820
    • ISO 14971, Product Risk Management and Risk Analysis techniques 
    • Clinical Study Design and Execution 
    • Post market surveillance
  • Technical skills in Medical Device industry processes
  • Strong analytical skills with the ability to organize work in a logical, thorough and succinct manner. 
  • Detail oriented and an active listener
  • Highly self-motivated, self-directed 
  • Ability to work under pressure
  • Flexibility to adapt to changing priorities 
  • Effective with written and verbal in English communications at all levels 
  • Authorized to work in the United States for any employer or proper documentation if associated with a third-party agency
  • Experience in dealing with FDA and handling Q-submissions, and other submissions

Nice to Have Competencies and Skills (Not Required):
  • Development/review of manufacturing processes maps and process FMEA, with critical points identification and mitigation
  • Development of process validation protocols (IQ-OQ-PQ) and writing of summary reports
  • Experience with Software as a medical device or cybersecurity quality requirements 
  • Regulatory experience (Drafting Q-Submission, 510(k), PMA, De Novo, etc...)
  • Niche Medical Device QA/RA expertise 
  • Experience in IVDs
  • Experience in process validation 
  • Experience with foreign regulatory or quality requirements (EU, Japan, UK, etc...)
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