Regulatory and Quality Solutions Names Julie Maes Director of Territory Operations – Northern Lakes Region

Maes brings 25+ years of medical device regulatory, quality, and project management experience to R&Q.

Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q), a provider of industry-leading regulatory and quality engineering services to medical device and combination product companies, announced that Julie Maes has been named Director of Territory Operations for Minnesota. An industry veteran of the global healthcare and medical device industry, Maes brings extensive management and hands-on quality systems development experience to R&Q’s expanding Minnesota area operations.

In her role at R&Q, Maes will manage designated resources to guarantee the highest quality consulting and complete customer satisfaction in the region. She will also contribute to R&Q’s Center of Excellence as a subject matter expert, providing industry education on the most critical and timely regulatory and quality challenges facing our market.

Background

Since 2013 Julie has served as an Adjunct Instructor in the Master’s in Medical Technology Quality (MTQ) Program at St. Cloud State University.

Prior to joining R&Q Julie served as Director, Documentation Services at St. Jude Medical / Abbott, a global healthcare company, where she directed the activities of Documentation Services, including a staff of 50+ across the US and two cost center budgets of $6+ million dollars annually.

Julie served as Sr Quality Systems Manager at American Medical Systems / Endo Pharmaceuticals, where she and her team managed systems and staff focused on quality system, software quality engineering and contract resources, documentation control, field actions, internal audit, statistical methods, and training systems.

Julie has also held positions at Boston Scientific Corporation as both a Manager, Quality System Projects, Quality Systems, Design Compliance and a Learning and Development Manager, Quality Engineering. Additionally, she has worked at Mentor Corporation and DataMyte Corporation.

On regulatory and quality changes and challenges

“Julie joins R&Q at an exciting time in the medical device industry,” said Maria Fagan, President at R&Q.  “Medical device and combination product companies are addressing many changes in the regulatory and quality requirements of the US, Canada, European markets, and all countries around world.  In particular, the release of the new EU Medical Device Regulation (EU MDR), the 2016 update to ISO 13485 and new requirements for Clinical Evaluation Reports (CERs) are burdening both regulatory and quality departments to meet the new requirements. Julie’s industry expertise and customer focus will greatly assist R&Q clients with ensuring a business balanced approach to these changing regulations.”

“I am thrilled to join this fast growing and passionate company. It’s exciting to see the investments R&Q is making to address the increasing demand for regulatory and quality consulting services to address the challenges facing our customers today,” says Maes.

About R&Q
R&Q exists to improve people’s lives; the patients, our clients and our team members. R&Q helps bring more safe and effective medical devices to market for both medical device companies and combination product companies. Leveraging our deep industry experience, our company provides solutions that help improve the world. Drawing on expertise across the entire medical device product lifecycle, R&Q is uniquely positioned to present a range of strategic and tactical options and execute on the solution that best suits our clients’ individual regulatory and quality needs. R&Q’s headquarters are in Pittsburgh, PA with additional offices in Cleveland, OH, Boston, MA, Minneapolis, MN and Philadelphia, PA. From these offices, we service both nationally and internationally. R&Q is 100% women owned and is a certified Women’s Business Enterprise by WBENC.