NeuAge Institute (NAI)

Looking to Pursue a Career at a Medical Device Company? Consider a Pharmaceutical Regulatory Affairs Certification

regulatory affairs courses
Medical device companies are key players in the future of the pharmaceutical industry. They
work to produce innovative new technologies that healthcare professionals and consumers need every day. For every piece of medical equipment out there, there’s a whole team of specialists who are needed from the research and development stage to the sales and marketing stage. Specifically, regulatory affairs professionals play an important role in greenlighting the pathway of these devices to clinical trial and distribution.

If you’re interested in studying the field of regulatory affairs, find out how you can take your knowledge and experience to the rapidly expanding industry of medical devices.  

Understand the Framework Around Medical Devices

As a regulatory affairs professional, it’s your job to offer expertise on the current regulatory frameworks surrounding pharmaceutical products. When it comes to medical devices, that means understanding the different stages they must go through in the manufacturing and post-approval stages. 

For medical device companies in the USA, there exist regulatory frameworks around establishment registration, medical device reporting, quality system, labeling, premarket notification, and more. By providing the appropriate level of regulatory oversight, you can help medical device companies remain vigilant of the current requirements surrounding the production of new equipment.  

Students earning their regulatory affairs certificate at the NeuAge Institute will gain a good understanding of the current regulatory framework around medical devices, FDA regulatory submission requirements, manufacturing control, post approval compliance, good manufacturing practices (cGMP), and quality concepts.

regulatory affairs certificate
Regulatory affairs courses will give you knowledge of the regulatory frameworks around medical devices

Help Bring Medical Devices to the Market

New and innovative medical devices continue to grace the U.S. and global markets. Medical device companies now have the ability to use 3D printers to deliver everything from prosthetic and artificial parts to mobile health applications and surgical tools. 

First and foremost, regulatory controls are designed to provide consistent requirements to foster predictably safe and effective medical devices on the market. As a regulatory affairs professional working at a medical device company, you’ll help to uphold those standards and bring high-quality medical devices to the healthcare field. 

To do so, you’ll need to identify the product, its purpose in terms of use and target patient demographic, and its regulatory classification. The classification will generally indicate the appropriate regulatory pathway required for the device, in other words, the stages it must go through to be cleared for market release. 

Upon completion of the program at the NAI, you’ll have sufficient knowledge and insight into the current U.S. Professional Regulatory Affairs pathways for medical devices, along with European and International Regulatory Submissions. 

pharmaceutical regulatory affairs
Clear pathways for medical devices on the market

Gain Practical Experience in the Field of Pharmaceutical Regulatory Affairs

The NAI’s comprehensive program has been developed by industry and educational experts to align with current requirements and trends in the pharmaceutical industry. In a course specifically covering medical devices, students will explore clinical trial implementation, the identification and evaluation of sites and investigators, and the coordination of subject participation. 

Students benefit from an applied and practical approach to pharmaceutical regulatory affairs training which is complimented by hands-on projects that challenge students to apply their knowledge to real-world situations. For example, students should be able to demonstrate the skills of effective clinical trial administration for medical devices upon completion. 

The NAI partners with a wide network of companies and businesses within the pharmaceutical industry, offering co-op and job placement opportunities to help students enter their desired roles quickly. With the right combination of industry knowledge, experience, and support, you’ll be ready to start your career in the regulatory department of medical device companies.

Are you interested in taking regulatory affairs courses?

Start your career at NeuAge Institute today!




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