ELEXES Medical Consulting Pvt Ltd is a leading player in the medical consulting industry, offering specialized services in regulatory affairs (RA) and quality assurance (QA) for the medical device sector. The company supports global clients in navigating complex regulatory landscapes, ensuring compliance, and delivering high-quality products. ELEXES is renowned for its innovative approach to medical device consulting, providing technical advice, documentation services, and expertise in regulatory submissions and quality systems.
Job Responsibilities: Project Associate – RA/QA
As a Project Associate – RA/QA at ELEXES Medical Consulting, you will play a vital role in supporting the company’s mission to deliver top-notch regulatory and quality assurance services to its clients. Your key responsibilities will include:
- Active Team Participation: Be an active and collaborative team member on onboarded projects and tasks.
- Project Tracking: Keep track of all action items throughout the project’s lifecycle.
- Timely Deliverables: Ensure that deliverables are executed accurately and on time.
- Documentation Updates: Regularly update project tracking documents, including project plans, action item trackers, timesheets, and Trello boards.
- Support Across Verticals: Work across various departments, including clinical (e.g., clinical evaluation reports), product (e.g., design control documentation), quality (e.g., QMS compliance), and regulatory (e.g., 510k submissions).
- Draft Technical Documents: Support the drafting of regulatory documents, such as 510k submissions, technical files, risk assessments, and design history files (DHF).
- Regulatory Submission Support: Assist with worldwide regulatory submissions like 510(k), FDA correspondence, and more.
- Quality Audits: Support quality audits from both product and regulatory perspectives as needed.
Qualifications and Skills
The ideal candidate for the Project Associate – RA/QA role at ELEXES should meet the following qualifications and skills:
- Educational Background: A Bachelor’s or Master’s degree in Biomedical Engineering, Medical Electronics, or a related field is preferred.
- Industry Knowledge: A strong understanding of medical device technologies, regulatory requirements, and quality systems is highly desirable.
- Experience: While prior experience of 0-6 months is preferred, fresh graduates with a keen interest in medical devices are also encouraged to apply.
- Learning Ability: Ability to quickly learn and adapt to new challenges in a fast-paced environment.
- Interest in Medical Device Innovation: A passion for innovation in medical devices is essential.
- Communication Skills: Excellent verbal and written communication skills in English, with the ability to convey complex information in a simple manner.
How to Apply for the Project Associate – RA/QA Position
If you meet the qualifications and are excited about this opportunity, please send your updated CV to lisa@elexes.com. Be sure to highlight your relevant skills, educational background, and any experiences related to medical device regulations or quality systems. Don’t miss the chance to join a dynamic, data-driven team that is making a difference in the medical device industry.
