Job Summary
Position: Project Associate – RA/QA
ELEXES Medical Consulting Pvt Ltd offers you a challenging and rewarding role. As a Project Associate – RA/QA, you will be responsible to support the company in best serving its Clients by creating technical documents, providing technical advice, and ensuring the utmost quality and accuracy at all times. You will be part of a growing data-focused Regulatory and Quality technical team and will be able to work across a diverse portfolio of clients and international projects.
Roles and Responsibilities
-Being an active team member in the projects being onboarded and tasks being assigned
-Keeping track of the action items being worked upon during the entire course of the projects.
- Responsible for timely, accurate, and efficient execution of the deliverables
- Update documents generated for the purpose of project tracking and platforms that are relevant to the projects are updated i.e., project plan, action item tracker, timesheets, project folders, and Trello board
- Work with the four major verticals of Elexes, namely, clinical (clinical evaluation reports, post-market surveillance, period safety reports, etc.), product (design control, software, and hardware product documentation, testing, V&V, risk assessment, hazard analysis, etc.), quality (QMS compliance, audits, and certification, etc.)), and regulatory (510k, CE, international, CDSCO
submissions, etc.), as applicable
- Draft design or regulatory documentation, as per project requirement. A few are below
-Draft 510k/HC submission as per regulatory requirements
-Compile technical file and GSPR as per EU requirements
- Create or remediate Design History File (DHF) of Medical Device
- Draft of Product and Software Documentation
- Draft verification and validation test protocols
- Draft FMEAs and risk assessments
- Support the efforts associated with worldwide regulatory submission (e.g., 510(k) Submissions, FDA
correspondences) as assigned
- Sound knowledge of quality systems and support during quality audits from Product/regulatory standpoint, as needed
-Profound knowledge of the medical device industry and medical device regulations, including pertinent standards and guidelines
- Create/update standard work instructions, templates, procedures and other documents, to assist the project execution, as required
- Contribute to training materials
Desired skills/education
- Bachelors or Masters degree in Biomedical Engineering, Biotechnology, Electronics and Instrumentation Engineering or Mechanical Engineering
-Good knowledge of concepts and understanding of various technologies used for the creation of medical devices.
-Ability to learn and adapt quickly
- Interest in medical device innovation
- Excellent English writing and verbal skills
Freshers to 1 year experince can only apply.
Please share cv with [email protected] or DM
