Biomedical Engineering Jobs Elexes - Apply for RA/QA Post
"Want to Be a Part of the Medical Device Revolution? Join Our Team as an RA/QA Specialist Today!"
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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].

Keywords: RA/QA Specialist, medical device manufacturing, regulatory, quality systems, biomedical engineering, healthcare industry, remote job. Biomedical Engineering Jobs Elexes – Apply for RA/QA Post. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like TwitterTelegramFacebook and Instagram.

Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.