What is Medical Technology Regulatory Affairs?
Regulatory Affairs, also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Pharmaceutical companies use all the data accumulated during the discovery and development stages in order to register the drug and market the drug.
Regulatory professionals are responsible for keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products, advising on legal and scientific restraints and requirements and collecting, collating and evaluating scientific data.
What 3rd level courses are available?
Universities and colleges in Ireland are offering courses in Medical Technology Regulatory Affairs in the following subject areas:
- Medical Technology Regulatory Affairs and Quality – This course will link the existing regulations to regulatory requirements and how those requirements are executed across the medical device lifecycle.
- Regulatory Affairs: Specialist Diploma – Specialist diploma in regulatory affairs and processes.
- Pharmaceutical Regulatory Affairs – Develop knowledge of the design, development, analysis and production of medicines, the drug industry and regulatory affairs.
- International Regulatory Affairs – This programme will provide participants with an understanding of the processes for providing regulatory support to the facility ensuring compliance with ICH, EMA and FDA legislation.
Studying Medical Technology Regulatory Affairs in college
There are many courses in Medical Technology Regulatory Affairs that may take place over a few days, weeks or even 1 year to 4 years depending on the course and modules selected. There are also part-time courses and night courses available so you can be sure to fit in your studies no matter what your schedule is like.
Courses will cover theory work through lectures, assignments, tutorials and taught modules. Assessments will take place on a continuous basis with written examinations and practical assignments combined in order to achieve a qualification.
You could also consider work experience or a work shadow in the industry. Relevant work experience is a good way of demonstrating a genuine interest in the field and is regarded favourably by employers. Work Experience will not only give you the opportunity to obtain a deeper knowledge and understanding of the industry, it will also give you a chance to do some essential networking with other industry professionals and gain valuable contacts for the future.
Career options
After completing a Medical Technology Regulatory Affairs course you will be able to get started in a career that uses specific knowledge of licensing, marketing and legal compliance of a range of pharmaceutical and medical products in order to control their safety and efficacy.
As a regulatory affairs officer you will be the crucial link between your company, its products and regulatory authorities. You’ll combine your knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a range of companies, meet the required legislation.
Typical employers include companies that develop and manufacture agrochemicals, biotechnology, cosmetics, food/nutritional products, herbal and homoeopathic products, medical devices, pharmaceuticals and veterinary products.
It can take time to progress in the early stages of your career due to the demand for a range of skills and experience. However, further on, it’s possible to move relatively quickly into a more senior role as long as you can show you have the required level of competency. Regulatory affairs offer good opportunities for growth. As you gain experience you may be able to move from a junior administrative role into a more senior role with advisory functions.
Working hours will depend on whether you are self-employed, employed by a company with set business hours or if you are contracted to various facilities or companies. Working hours can include regular extra hours to meet tight deadlines, but not weekends or shifts.
Related jobs include:
- Regulatory affairs officer
- Academic researcher
- Biomedical scientist
- Clinical research associate
- Clinical scientist, biochemistry
- Clinical scientist, genomics
- Clinical scientist, haematology
- Clinical scientist, immunology
- Research scientist (medical)
- Anatomical pathology technologist
- Higher education lecturer
- Medical sales representative
- Medical science liaison
- Naturopath
- Physician associate
- Prosthetist
- Orthotist
- Science writer
Further study
After completing a course in Medical Technology Regulatory Affairs you may choose to pursue further study in a specialist field to increase your knowledge base and skill set. Postgraduate study can also be used as a means to change career focus or to gain professional qualifications required to practise in certain career areas such as biochemistry, biology, biomedical engineering, biomedical science, biotechnology, chemical and physical sciences, chemistry, engineering, medicine, pharmacology and pharmacy.
FAQ
What skills could be helpful for a career in Medical Technology Regulatory Affairs?
Working within the regulatory affairs department requires an equal measure of subject knowledge and soft skills. An individual must possess Drug development lifecycle knowledge, attention to detail, critical thinking and data analysis skills, good writing skills, excellent oral and written communication skills, organisational and project management skills and the ability to keep up to date on current regulations.
Most of these skills can be learnt as part of on-the-job learning. However, the role requires an individual to go through a lot of documents and be able to analyse information quickly and accurately so a passion for such work is very important.
Where can I study Medical Technology Regulatory Affairs?
Explore your options here
Did You Know?
- The medical technology industry has not only increased the quality and length of human life, but it has also produced many jobs with Medical Equipment Manufacturing now the 6th largest employer.
- Rene Laennec, a French surgeon, is credited with creating the first stethoscope in 1816. It was just an ear trumpet pressed against the chest. It was, however, one of the first occasions when doctors tried to grasp the inner workings of the body without cutting a patient open.
- The development of multiple safe and effective Covid-19 vaccines in less than a year may be remembered as one of the greater scientific accomplishments in human history. The process was sped along not only by regulatory fast-tracking but also by innovations in the ways medical trials are conducted: virtual clinical trials, held mostly online, eased the burden of participation. Combined with a spirit of collaboration rather than competition between pharmaceutical companies, they could pave the way for a bright future in drug development.
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