Company Description

MakroCare is an expert Regulatory Consulting and Clinical Services partner for the pharmaceutical, biotechnology and medical device industries. With operations and presence in the US, UK, EU, and Asia, we provide our global/regional teams and fit-for-purpose costing models to your development strategy, regulatory management, clinical research, medical/scientific support and quality assurance areas.

Trainee Product Engineer

This is a full-time, on-site role located in the Greater Hyderabad Area for a Trainee Product Engineer.

Qualifications

Only B.Tech / M.Tech in (BME) Biomedical Engineering (education background only) 2022 / 2023 passouts.

• Good knowledge of USFDA & EMEA guidelines.
• Knowledge of 21 CFR Part 11 for regulatory compliance in alignment with client objectives.
• Knowledge of interpreting the Regulatory requirements
• Knowledge on Medical Device Regulatory Guidelines, Literature search on regulatory requirements including labeling information, the registration process
• Ability to understand the purpose and requirements of the assigned project and deliver consistently high-quality clinical/regulatory documents that meet project requirements.
• Liaising with medical, biomedical engineering, scientific and clinical staff
• Good time management, meeting deadlines and commitments.
• Good Communication skills, Listening skills, and Problem-solving skills.
• Good knowledge of usage of MS Office applications