A Guide to Medical Device Job Opportunities and Careers

by Barkha Pahuja SEO/Writer

Medical devices are essential for the safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease. By aiding natural physiological processes and providing important clinical data, they are crucial for safeguarding the health and wellbeing of people all across the globe.

With plenty of opportunities for travel, professional development and international employment — as well as the opportunity to make a positive impact on public health — there’s never been a better time to work in the field.

What the role of Medical Device QA[Quality Assuranace] & RA [Regulatory Affairs]Professionals?

QA professionals; Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support. Oversee the continual improvement of medical devices as well as the design and manufacturing of new devices.

Should have knowledge about technical file preparation, current document control processes in the development, manufacture and distribution of medical devices, Internal Audits, Supplier Audits, Health Authority Audits etc

RAAJ GPRAC provides 3 months course in Medical device QA that will provide a thorough understanding on

• _{QMS as per ISO 13485:2016,} Risk Management as per ISO14971:2019, CAPA, Change Management, The medical device regulatory process in USA, 510(k) submission, PMA submission, Europe (EU-MDR) and India(MDR 2017and SUGAM portal submission for regulated and non-regulated devices, Submission to BIS for ISI marking which will help them to become a successful QA professionals and INTERNAL AUDITORS.

Regulatory affairs[RA] professionals

Plays an important role, advising the team on appropriate regulatory strategies to ensure the product can be legally marketed. They should have a sound knowledge and understanding of Global regulatory System for Medical devices which will help them to create a thorough understanding of important regulatory filing concepts across the Globe. They should have through knowledge QMS as per ISO13485:2016, ISO14971:2019, MDSAP and technical file documentation.

RAAJ GPRAC provides 6 months course for global medical device regulation wherein they will learn about

Global Medical device Industry, Premarket notification-510(k), PMA (Premarket Approval),De Novo Classification Request, Labeling requirement in US, New MDR in EU, Notified Bodies, CE Marks, Indian MDR 2017 and regulation in countries like Health Canada, Australia-TGA, Japan-PMDA, China-CFDA, Middle East-GCC, QMS as per ISO13485:2016, ISO14971:2019, MDSAP and technical file documentation.

CAPA, Design and development till Life cycle Managemnt of medical device along with Clinical testing and safety testing and technical file preparation.

Workplace Environment

Work is largely office-based, although you may be responsible for a certain geographical region, so you may be expected to travel to meet with clients, Audits etc. It is possible to work for yourself or as a freelancer. The great majority of medical device sales regulatory professionals work full-time, 9-to-5 hours.

Qualification For Medical Device Regulatory Professional[QA/RA]

Diploma in biomedical / medical electronics / electrical / any other related filed.

B. E / B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering / Medical Electronics / any other related field.

All those who have completed their Graduation or Post Graduation in Life Science/ Pharma / PhD

Graduates and experienced professionals alike should consider undertaking training courses; the addition of a regulatory-specific qualification to your CV will have added importance and value. RAAJ GPRAC provides a range of courses for candidates interested in making their career in medical device industry.

Website - https://raajpharmaelearning.com/


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Created on Jan 7th 2022 05:40. Viewed 231 times.

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