Regulatory Affairs Diploma: Reconstructive, Medical, Surgical, and Neurotechnological Devices
By: Evelina Sodt
Tags: Evelina Sodt, Regulation, Medical Devices, Professional Development, Compliance

The Diploma Course is $55 and it comes with a reference guide. Add an in-demand skill to your resume today.

Photo Credit: Christina Morillo

Why There Is a Need

Regulatory affairs professionals direct submissions to regulatory health agencies (FDA, ICH, etc.) while leveraging relationships within their organizations. They also manage regulatory information, document management, and publishing.

Positions within the regulatory field offer excellent job security, and usually require only a bachelor’s degree (in any discipline) from an accredited university. While some companies prefer science or engineering majors, other find the skills of communications or economics graduates more appealing.

As the FDA is increasing its standards, more supporting studies are required and more paperwork has to be created, organized and stored.

The business of regulations, within the US, is going to have to change. New technologies and automation are capable of stepping in right now, however, this type of necessary bureaucracy has legs and projected longevity.

Companies have to protect themselves through meticulous documentation and cross-functional partnerships. And to stay in business companies have to proceed with forward vision, as obsolescence and advances must procure innovation. Therefore, the need for documenters, organizers, scribes and submission experts with continue to increase.

Internal Regulator Qualities

You must be a meticulous, detail-oriented scribe with a love for organization and documentation of reports, metrics, proposals, and presentations.

You must be a team player who enjoys building and maintaining intra-departmental relationships with insightful people who can help you envision ongoing improvement in process streamlining.

You must be driven and committed to making sure all projects meet standards, regulations and expectations.

You must be willing to log every conversation with a co-worker and a regulator, while staying focused on achieving success.

What Do Regulatory Affairs Specialists Do?

As the Regulatory Affairs Specialist you will support the entire product life cycle, from birth through obsolescence. You will document changes made, and you will use creativity to register with minimal regulatory impact. You will not only ensure regulatory compliance / clearance by the FDA, Notified Bodies, and other regulatory agencies, you will also manage information sources and contacts for local, regional, and global regulation considerations.

It will be up to you to manage standard operations procedures (SOPs). Create a process, share, train, and systematize based on:

organization and documentation,

continued regulatory education,

evaluation of proposed products,

research requirements (local, national, international),

standards for regulatory submissions,

approval steps and tracking status,

and compliance activities.

Interested in a Regulatory Affairs Diploma?

Get a professional handle on CFR, MDD, 510K, QSR, ISO 13485, and MDSAP (International Regulation and Standards) today!