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:
- AI-powered multimodal data harmonization and analytics for drug discovery and development
- IVD development, validation, and regulatory approval
- 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?
- Support implementation of Integrated Management Systems SOPs
- 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)
- Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained
- Participate in assigned continuous improvement initiatives
- Conduct activities related to internal and external audits as assigned
- Track Non-Conformities and CAPAs to closure cross organization
- Timely monitor and report on KPIs
What do you bring to the table?
- BS Degree in Computer Science, Information Technology or Biomedical Engineering or equivalent degree
- 5+ years of relevant industry experience with demonstrated achievements in the areas of responsibilities mentioned above.
- 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, Annex11
Benefits:
- Flexible Work & Time Off - Embrace hybrid work models and enjoy the freedom of unlimited paid time off to support work-life balance.
- 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.
- Growth & Learning - Fuel your professional journey with continuous learning and development programs designed to help you upskill and grow.
- Recognition & Rewards - Get recognized for your contributions through structured reward programs and campaigns.
- Engaging & Fun Work Culture - Experience a vibrant workplace with team events, celebrations, and engaging activities that make every workday enjoyable.
- & Many More...
