About Velsera
Medicine moves too slow. At Velsera, we are changing that.
Velsera was formed in 2023 through the shared vision of Seven Bridges and Pierian, with a mission to accelerate the discovery, development, and delivery of life-changing insights.
Velsera provides software and professional services for:
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AI-powered multimodal data harmonization and analytics for drug discovery and development
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IVD development, validation, and regulatory approval
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Clinical NGS interpretation, reporting, and adoption
With our headquarters in Boston, MA, we are growing and expanding our teams located in different countries!
What will you do?
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Support implementation of Integrated Management Systems SOPs
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Support all phases of the product life cycle (including, but not limited to requirements development/review/approval, test planning, test execution, and test reporting and assessment)
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Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained
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Participate in assigned continuous improvement initiatives
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Conduct activities related to internal and external audits as assigned
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Track Non-Conformities and CAPAs to closure cross organization
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Timely monitor and report on KPIs
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Provide quality related trainings
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Collaborate across teams to deliver the responsibilities
Requirements
What do you bring to the table?
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BS Degree in Computer Science, Information Technology or Biomedical Engineering or equivalent degree
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5+ years of relevant industry experience with demonstrated achievements in the areas of responsibilities mentioned above.
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Sound knowledge of Industry standards: (e.g., ISO 13485,) and good understanding of Regulatory requirements: 21 CFR Part 820 & Part 11, EU MDR or IVDR, Annex 11
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Good understanding of agile software development support ways of implementing agile principles in a regulated environment.
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Fluency in English
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Knowledge & experience of managing compliance using software tools
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Quick learner, self-driven & self-organizing and able to work independently
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Proactive and with ability to take initiative
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Precise, accurate, with an eye on details and can to attitude
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Very good oral, written communication, and presentation skills
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Good understanding of information security domain (ISO 27001) is a plus
Benefits
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Flexible Work & Time Off - Embrace hybrid work models and enjoy the freedom of unlimited paid time off to support work-life balance.
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Health & Well-being - Access comprehensive group medical and life insurance coverage, along with a 24/7 Employee Assistance Program (EAP) for mental health and wellness support.
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Growth & Learning - Fuel your professional journey with continuous learning and development programs designed to help you upskill and grow.
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Engaging & Fun Work Culture - Experience a vibrant workplace with team events, celebrations, and engaging activities that make every workday enjoyable.
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& Many More...
