The medical device Industry offers masses of possibility for personnel. In America alone, more than 9000 medical device companies hire greater than 480,000 employees who earn salaries that are more than 48% higher than the national average. Job prospects within this industry are various, however the developing nature of the sector guarantees that there are interesting and stimulating roles available for skilled graduates all through the many regions of the field.
The Skilled NanoDegree in Medical Device Regulatory Affairs (MDRA) offers understudies with the chance to aptitudes to employers and peers, and to improve profession in regulatory affairs by creating expanding levels of capability and competence. It is the ‘highest quality level’ in the field. This Nano Degree furnishes graduates with a progressed hypothetical comprehension of the procedures and practices vital to medical device regulatory affairs. Graduates can move into regulation jobs as well as be indorsed inside their association.
Understudies will increase priceless access acquire a conventional capability in the medical device regulation industry. The program presents a wide perspective on the regulatory affairs job and gives a nitty gritty understanding into current and proposed EU enactment. It furnishes understudies with a progressed hypothetical comprehension of the procedures and practices vital to medical device regulatory affairs.
The course will empower Regulatory Affairs work force in the Medical Technology industry to comprehend all present device and diagnostic regulations and to build up the aptitudes important to address and get ready for the ever-changing worldwide environment of regulatory affairs.
- To produce graduates with the indispensable breadth and kind of knowledge, skills set and capabilities required to function as a regulatory affairs expert in the medical device industry and to be proficient for an immediate contribution to regulatory projects and projects with a regulatory element in a medical device company environment.
- To assure that participants bang ample skills and knowledge to employ innovative data analysing, synthesising, summarising and investigate skills in a regulatory environment.
- To make sure that participants can successfully communicate and shield medical information and findings in a ramification of forms to regulatory agencies, medical care systems, internal employees and the general public.
- To make sure participants have the skills and potential to function inside, and adapt to, a changing technical work environment and evolving regulatory frameworks.
- To make certain the participants can offer premeditated, tactical and operational route and help for working inside regulations to expedite the development and delivery of secure and powerful healthcare merchandise to people around the world.
Working and collaborating online, students will conduct a practical, in-depth analysis on how emerging developments and trends are reshaping the regulation of medical devices in the globally., as well as reviewing global markets and regulations. This Skilled program also examines related legal issues such as intellectual property, patents, and licensing, and considers the social and financial impact of the medical devices industry on the aging population.
The Skilled Nano-Degree in Medical Devices Regulatory Affairs online program presents an in-depth practice of regulations relating to the processing of medical devices, including those products not specifically regulated by federal law. Employed and collaborating online, students will conduct a operable, in-depth psychotherapy on how emerging developments and trends are reshaping the prescript of medical devices in the globally., as well as reviewing world markets and regulations. This Skilled program also examines concerned legal issues much as intellectual property, patents, and licensing, and considers the gregarious and financial impact of the medical devices business on the senescence accumulation.
- 9 out of the world’s 10 medical device companies are located Globally
- €14.6 billion in exports
- Over 45,000 employed
- Over 65% are engaged in R&D
- Over 9,000 new jobs predicted by 2023
Career opportunities include roles in the following areas; Medical device manufacturing, process/product design, manufacturing/ operations, regulatory affairs/compliance, technology transfer, validation, automation, operational excellence, quality control/ quality assurance, computer systems and data analytics. Initial salary will vary considerably dependent on entry role and experience. Typically, anyone doing a postgraduate diploma is already working and has experience within the sector. The salary expectation would be €35-€55k but could easily be up to €100k.
- Module 1 – Introduction to Global Regulatory Authorities for pharma and healthcare industries
- Module 2 – Medical Devices, In –vitro devices, Biologics & Combination Products
- Module 3 – Medical Device Development, A Regulatory Overview
- Module 4 – Emerging Trends and Issues in the Medical Device Industry
- Module 5 – The Business of Medicine and Biotechnology
- Module 6 – Combination Products and Convergence
- Module7 – Biomedical Intellectual Property Management: Patents, Trademarks, Copyrights, Trade Secrets, and Technology Licensing
- Module 8 – Global Awareness: European Medical Device Regulations
- Module 9 – Japanese Medical Device Regulations and Registrations
- Module 10 – Canadian and Australian Medical Device Regulations
- Module 11 – Global Awareness: Emerging Medical Device Markets
- Module 12 – Food, Drug, and Medical Device Law: Topics & Cases
- Module 13 – Regulatory Writing: Medical Device Submissions
- Module 14 – Technology Licensing
- Module 15 – FDA Regulations and Guidelines on Medical Devices
- Module 16 – European Union Regulatory Guidelines on Medical Devices
- Module 17 – Medical Device Regulations from Indian perspective
- Module 18 – Management of the risks associated with Medical devices
- Module 19 -Biocompatibility Studies and Medical Devices
- Module 20 – Clinical Trials: Medical Devices
- Module 21 – Overview of In–Vitro Device Regulation
- Module 22 – Overview of Combination Products Regulation
- Module 23 – Medical Device Registration, e-Submissions and Approvals in US, Europe and India
- Online application
- Statement of purpose (500-1000 words)
- Professional resumé
- Unofficial undergraduate transcripts
- Two letters of recommendation
- English Language Proficiency Proof
All those working in the Pharmaceutical Industry or any sector of healthcare or any other industry type (Globally) can apply. Life Science Graduate /B.Pharm/M.Pharm/M.Sc/ or passed out of Clinical Research Degree are also eligible for the course. Working Professional of any of the following industry types Food Manufacturing, Food Industry and Additive Processing, Drugs Manufacturing, Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry are highly encouraged to apply for the programme.
Minimum time in which a student can complete this diploma course is 12 months while a maximum of 24 months is allowed to complete the course.
Students who wish to apply to this course should follow the following application process. They should have obtained a Level 8 Honours degree in Science, Engineering or a related discipline.
First of all, you will need to complete and submit an enquiry form, located at the top of this page. This is to register interest with us in the chosen course. Once submitted a member of the team will be in contact with you via phone call or email to discuss the course in more detail, assess your eligibility and assist you with anything you need to progress further.
Subject to eligibility, the next step is too to fill out and submit the application form which will require you to submit the following documentation
- A copy of your CV
- Copy of a Government issued ID (passport or driver’s licence)
- Transcript of your previous highest qualification.
We accept scanned documents in a pdf format. Pictures of documents are not accepted.
Following the submission of your application form, a member of our team will be in contact with you.
Please note through the application process if you have any questions please do not hesitate to contact us by email on firstname.lastname@example.org.
All the participants are obliged to timely submit completed assessment assignments (during the course, usually after every module) and appear for an online exam at the end of the course. After successful completion, the participants will be awarded Skilled Nano-Degree in Medical Devices Regulatory Affairs by BBMInstitute.
For all the above-mentioned modules elaborate course material, self-assessment assignments and project work details would be provided by the BBMInstitute from time to time. Details get updated on the webpage as well.
BBMInstitute offers placement assistance to its students. The BBMInstitute has partnered with many organizations for providing placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting employability of our participants. The efforts of our placement cell also include helping with professional resume writing & interview skills. In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare, Medical devices and food giants like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Biocon , Hindustan Syringes & Medical Devices, Wipro GE Healthcare, Medtronic, Bausch & Lomb, Baxter, Sushrut Surgicals, Wipro Technologies, HCL Technologies etc.
Medical Devices Industry is highly alluring sector now a days. Hence, there is fierce competition in this sector. Proper training and knowledge in this field is required so as to reach the pinnacle of success in this particular sector.
Skilled Nano-Degree in Medical Devices Regulatory Affairs is a broad spectrum course which endows theoretical as well as practical knowledge to the candidate required to sustain successfully in industry. After the completion of this course the candidate gets selected in industry/sector of his/her interest. This course is also beneficial for working professionals to gain hike in their sector by getting updated knowledge of the field.
- Biomedical Engineering
- Process / Product Design
- Manufacturing / Operations
- Regulatory Affairs / Compliance
- Validation / Automation
- Operational Excellence
- Quality Control / Quality Assurance
Our Professional Development team, through individual coaching and mentorship, develop each individual student to their greatest potential – developing their networking and communication and presentation skills, which ensures that graduates develop a suitable career path. This Career Development strategy has proven to be very successful, with over 70% of BBMInstitute graduates gaining employment or advancing further their careers in the industry within six months of qualification.
As a result of our proven track record, many organisations and recruitment agencies now contact us directly, requesting students to fill open roles they have.
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