‘An Invisible Profession’: Scarcity Of Quality/Regulatory Experts A Call To Action For Educators
• By Shawn M. Schmitt
Online-Only Content >>> As baby boomers retire, device manufacturers are scrambling to fill quality and regulatory positions – particularly those in leadership roles, according to an industry survey. Yet many firms are discovering that a number of younger employees – those who typically fill gaps left by retiring managers – have not cultivated the necessary quality and regulatory skills demanded by today's complex global market. "A person going into QA/RA now is not going to be only an expert on United States requirements. Rather, that person has to be educated about global requirements," University of Southern California's Frances Richmond says. The industry survey also noted that a prospective employee's so-called soft skills, such as writing and verbal communication, are deeply valued by manufacturers. Meanwhile, more than 20 universities have banded together to create the Association of Graduate Regulatory Educators to promote QA/RA professions.
FDA's increased emphasis on medical device quality, combined with new and ever-changing regulations from around the world is making it increasingly difficult for manufacturers to find qualified professionals to fill openings in their QA/RA department rosters.
As baby boomers retire, firms are scrambling to fill QA/RA positions – particularly those in leadership roles, according to a 2013 industry survey coordinated by Arlington, Va.-based Compliance-Alliance. Respondents to...
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