‘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...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
Increased support for NHS services and delivery infrastructure announced in the 11 June government spending review by chancellor of the exchequer Rachel Reeves could boost inward investment and offer new market opportunities for medtechs.
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
