Trainee Product Engineer BME - Hyderabad, India - Makro

Description

CompanyDescriptionMakroCare is anexpert Regulatory Consulting and Clinical Services partner for thepharmaceutical biotechnology and medical device industries. Withoperations and presence in the US UK EU and Asia we provide ourglobal/regional teams and fitforpurpose costing models to yourdevelopment strategy regulatory management clinical researchmedical/scientific support and quality assuranceareas.
TraineeProductEngineer
Thisis a fulltime onsite role located in the Greater Hyderabad Area fora Trainee Product Engineer.
Qualifications
OnlyB.Tech / M.Tech in (BME)Biomedical Engineering (education background only)2022 / 2023passouts.

• Goodknowledge of USFDA & EMEAguidelines.
• Knowledge of 21 CFR Part 11 forregulatory compliance in alignment with clientobjectives.
• Knowledge of interpreting theRegulatory requirements
• Knowledge on MedicalDevice Regulatory Guidelines Literature search on regulatoryrequirements including labeling information the registrationprocess
• Ability to understand the purpose andrequirements of the assigned project and deliver consistentlyhighquality clinical/regulatory documents that meet projectrequirements.
• Liaising with medical biomedicalengineering scientific and clinical staff
• Goodtime management meeting deadlines andcommitments.
• Good Communication skillsListening skills and Problemsolving skills.
• Good knowledge of usage of MS Officeapplications

biomedicalengineering,clinical research,regulatory requirements,clinicalservices,cfr