Biomedical Engineering Jobs Elexes – Apply for RA/QA Post
We are hiring!
Position: RA/QA Specialist
Company Overview:
At Elexes, we are a leading medical device manufacturing company focused on delivering innovative solutions that improve patient care and enhance the healthcare industry. With a dedicated team of professionals and cutting-edge technology, we strive to make a positive impact in the medical field.
Roles & Responsibilities
Regulatory
- Conduct literature review, gather and present data relevant to submissions
- Research skills
- Documentation skills
- Ability to make sound decisions regarding when to escalate matters
- Draft/Assist in regulatory submission and related documents (US FDA, EU MDR, HC submissions using project management platforms) and Regulatory assessment of Engineering/ Design change execution with the assistance of technical managers
- Medical Device Technology – In-depth understanding of operating principles and working mechanism of medical devices, both diagnostic and ultrasound
- Sound knowledge of biomechanics and human anatomy
- Notify when compliance issues arise or are identified during regulatory review, and then another immediate action is required
- Basic knowledge of the regulatory domain and corresponding legal frameworks,
- Exposure to US FDA regulations and EU MDR is preferable
- Project management skills,
- Exposure to project management tools is preferable
- Diligence/Research skills
- Demonstrate commitment to assigned tasks and target to succeed beyond limitations
Quality
- Engage in daily deliverables of problem requests, complaint records, corrective and preventive actions, and change controls
- Assist clients in external audits, or assist clients in audit readiness
- Proficiency in written and verbal English skills is mandatory
- Performs a Regulatory watch to identify new or revised regulatory requirements
- Conduct technical reviews based on a review matrix
General
- Bachelor’s degree with hands-on experience. See, the “Skills” section above for more details
- Bachelor’s degree in Biomedical Engineering/Medical Electronics, with 2 years of experience in product specialist/field service engineer position with leading medical device manufacturing companies
- Master’s degree in Biomedical Engineering/Electronics Engineering/Electronics and Telecommunication Engineering with 1 year of experience in a product specialist
- Knowledge of quality systems (ISO 13485: 2016, EU MDR, MDSAP, FDA QSR 21 CFR Part 820, 14971)
- Experience in Internal, certification, and surveillance Audits
CTC: Competitive
Job Type: Full-time (remote)
How to Apply: Please share your CV with [email protected].
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