For me, leadership is about helping people and always doing what is best for the employee, the client, and the patients who need the devices we support.
With a clear roadmap, a reviewer can start with a high-level overview of the content and follow a path that makes it easier to determine whether the device meets that intended use with an acceptable benefit-risk.
When you’ve grown from three people in 2008 to just about 500 today, you need a way to scale the innovation you had as a startup. You have to bake innovation into the very DNA of your company from core values to automation.
RQM+ has deep knowledge and a stellar reputation in the world of biotech and we could not be more excited to work with them at this important stage of Notox's development. Finding the right group to lead us through this phase of the process is paramount for all our stakeholders.
The focus of why we exist is to improve people's lives. Whether it's the patients that are using the medical devices, our clients, or the team members that work at RQM+. That's the foundation upon which we built our company.
For me, leadership is rooted in the ability to serve the people who are part of the organization, and ensure they are always given the support they need. That has always been a recipe for success in the services business.
To address a global challenge like COVID-19, we have undertaken a worldwide effort to develop a well-tolerated and effective vaccine as quickly as science and cutting-edge technology will allow.
L'impact perturbateur du Covid-19 sur l'approvisionnement en médicaments et en dispositifs médicaux a mis sous pression de nombreuses équipes chargées de la réglementation et de la conformité. Même avant la pandémie, l'industrie des sciences de la vie subissait déjà d'importants changements réglementaires, et doit maintenant rapidement relever de nouveaux défis et priorités.
Given overdemand for notified bodies in the regulatory arena, an early start can make the difference between a product market freeze and full [MDR] compliance for market access.
Without reliable testing, treatment approaches can vary from center to center, inhibiting development of an evidence-based, industry-wide, accepted standard of care. Only time and hindsight will show if this approach is helpful or harmful in addressing growing concerns over the current global pandemic.
Every RQM+ employee from our executive team to our industry-leading thought leaders believes in delivering transformative solutions. Our subject matter experts include notified body leaders, former regulators, and members of committees that draft guidance documents. Our executive team consists of leaders uniquely driving business growth and ensuring client success. Our organization maintains deep industry connections with the FDA, various notified bodies, and health organizations worldwide, allowing RQM+ to be a leading source for current insight and best practices.
Margaret Keegan joins RQM+ with three decades of experience with executive roles at the largest life sciences service providers in the world, including PPD, IQVIA and, most recently, PRA Health Sciences where she was chief operating officer.
Keegan recently served as the chair of CDISC, the global authority defining clinical data and interoperability standards for life sciences and healthcare, and continues to serve on its board.
Prior to RQM+, she served as chief operating officer of PRA Health Sciences (now ICON), one of the world’s largest public contract research organizations and pioneer of digital models in research. Prior to PRA Health Sciences, Keegan served as president of clinical development for IQVIA, the world’s largest healthcare data science company, where she was accountable for the delivery and growth of the clinical development business. At IQVIA, she also served as president of data safety, regulatory, biostatistics and data management.
She is a mathematician and holds a bachelor’s degree in pure and applied mathematics from the University of Strathclyde and is also a chartered statistician.
Lisa co-founded R&Q in 2008, which was rebranded to RQM+ in 2020. As a member of the executive leadership team, Lisa supports strategic planning and execution, and provides guidance across the company. Lisa leads the RQM+ Marketing Team, focusing on creating and executing innovative marketing strategies to profitably increase revenue and grow the brand. She is responsible for managing all aspects of RQM+ marketing campaigns and operations.
Lisa has 20 years of industry experience, with extensive expertise in medical device RA/QA, and business development. Prior to co-founding R&Q, Lisa held positions at MEDRAD and the Tyco Healthcare Retail Group. Lisa’s previous positions included Senior Regulatory Affairs Specialist at MEDRAD, where she focused on worldwide submissions for product development teams and field safety risk assessments for product issues, and Process/Quality Engineer at the Tyco Healthcare Retail Group. Lisa holds an M.S. in Mechanical Engineering from the University of Delaware and a B.S. in Mechanical Engineering from West Virginia University.
Stephen Cottrell is the Chief Commercial Officer of RQM+ and is responsible for client service delivery, growth, and overall performance of the company. He leads an experienced team of industry professionals who formulate and deliver consulting services dedicated to the life sciences industry. Steve’s experience encompasses leading a wide array of business services within the life sciences sector, including business process outsourcing, strategic sourcing, and clinical trial offerings.
Serving as the President of Maetrics, which was rebranded to RQM+ in 2020, Steve is a business executive with more than 25 years of experience in the life sciences industry. His career has been dedicated to supporting services in the medical device, pharmaceutical, and biotech market segments. He has a proven ability to evaluate client challenges and bring together unique solutions to meet the current and future needs of clients.
Prior to joining RQM+, Mr. Cottrell was the Global Vice President of Business Development for DOCS, a division of the global Clinical Research Organization ICON plc. Prior to that, he served as Executive Vice President of Global Business Development at i3 Research, a division of United Health Group.
Mr. Cottrell is a business executive with 25-plus years of experience in the life sciences industry. His career has been dedicated to supporting services in the medical device, pharmaceutical, and biotech market segments. He has a proven ability to evaluate client challenges and bring together unique solutions to meet the current and future needs of clients.
Mr. Cottrell has a B.A. in Economics from Boston University.
Lori joined in 2012 providing technical expertise to RQM+ clients while focusing internally on employee leadership and development and the strategic growth of the Consulting Services infrastructure. Combining her strong technical skills with empowerment and compassion, Lori leads by example and has routinely demonstrated an ability to bring out the very best in her teams.
Under her leadership, Lori’s team has been consistently given, on average, 9+ on a scale of 10 for client satisfaction with a 90% repeat customer rate. As Chief Operating Officer, her entrepreneurial spirit has guided her to create the RQM+ operational model with a focus on people, process and tools. She has focused on operational excellence while ensuring the global scalability of the Consulting Services infrastructure.
Lori is responsible for developing and monitoring the consulting services team’s strategic goals, current objectives and overall operating budget. Her team consists of technically skilled consultants providing industry leading regulatory and quality consulting and engineering services along with program management expertise. The design and delivery team round out the consulting services team and is responsible for proposal development that focuses on successful delivery of services. Lori’s outstanding leadership and her ability to focus and direct teams towards accomplishing specific and measurable goals has been one of the backbones to the success of RQM+.
Lori has held various leadership positions within multiple industries over the past 18 years including medical device. Prior to joining RQM+, Lori was with MEDRAD and while there, led her team to Industry Week’s Best Plants and AME Manufacturing Excellence Awards.
Lori earned a B.S. in Business Administration with a concentration in Psychology from Clarion University. She also earned an MBA from Chatham University, an Executive Leadership Program certificate from Carnegie Mellon University’s Tepper School of Business and is a Six Sigma Green Belt. She has served as guest speaker at Saint Vincent College via the Kennametal Center of Operational Excellence.
Julie joined RQM+ in 2012 and oversees the financial, IT, and legal aspects of the company. Skilled in project management, Julie has led several successful large programs at RQM+ including most recently the re-design of the Business Development process and the implementation of the new ERP system. On a day to day basis, Julie is intimately involved in customer contract negotiations, profitability analysis, cash flow management, and short/ long term business, financial, and tax planning.
Julie’s career includes eight years of progressive financial planning & analysis and corporate development roles at MEDRAD, including global strategic planning, business unit financial management, portfolio optimization, and M&A financial modeling. She assisted with setting pricing strategy for new products, led product line closures from a financial perspective, and established a corporate-wide process for new product development financial decision making.
Prior to MEDRAD, Julie gained Big 4 Accounting experience as an Auditor with KPMG. She holds an MBA from the University of Pittsburgh with a Marketing concentration and a B.S. in Accounting from Saint Vincent College. Julie is an active CPA, has served as an adjunct Accounting Professor at Saint Vincent College and Westmoreland County Community College, and been a member of the Westmoreland County 4-H Board of Directors.
As the Chief People Officer, Trisha leads the Human Resources initiatives at RQM+ by establishing the HR strategy which includes a strong culture where top talent is engaged in meaningful work, feels significant and confident and is passionate about improving patients' lives.
Trisha joined RQM+ in June of 2014 as the first HR professional and has since helped RQM+ grow from 35 employees to over 450. She has established not only the HR foundational aspects for RQM+, which includes talent management, employee relations and benefits, but has also led and assisted with many strategic company initiatives.
Trisha has over 20 years of experience in Human Resources and has spent much of her career in medical devices working at Respironics (now Philips Healthcare), as well as other industries including Government Consulting and Nuclear. She also founded and ran her own Human Resources Consulting Company prior to joining RQM+.
Trisha holds a B.A. in Business Administration from Washington and Jefferson College and an M.A. in Industrial and Labor Relations from Indiana University of Pennsylvania. Trisha is a nationally certified Senior Professional in Human Resources (SPHR).
Amie joined RQM+ in March of 2020. A clinical and regulatory affairs expert, Amie has over 25 years of postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems, and clinical data evaluation. She is leading the RQM+ clinical team, following her role as former Global Head of Clinical Compliance at BSI. Amie developed BSI’s clinical compliance team and lead clinical aspects of successful MDR designation.
Joining RQM+ in 2015, Ronnie now leads the company through the integration of mergers and acquisitions as the Vice President, Integration & Chief of Staff.
Along with focusing on key strategic initiatives that support the growth of RQM+, Ronnie also provides strategic leadership and tactical execution across all elements of regulatory and quality for medical device and IVD companies.
GLOBAL BOTTOM CTA INSTRUCTIONS:
To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.
Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!