ORLANDO, FL – Some people say they thrive under pressure. Melinda Novatny actually proves it. Hand her a compliance mess with the clock running out, and she gets to work like she’s been doing it her whole career, because she has.
“I like to find a challenge. I like to put together puzzles, and solving the puzzle is really, really important to me,” she said. “Once I solve it, I move on to the next one. I guess that makes me a firefighting Miss Marple, and I’ll happily take it.”
Novatny, QualityHub’s new Senior Principal Consultant, brings roughly 25 years of industry experience in regulatory affairs and quality systems, along with a track record of being the person to call when a project goes sideways.
Novatny spent nearly 13 years at Philips Healthcare, where she built a reputation for handling the highest-stakes correspondence a quality or regulatory team can produce and rose to Director of Regulatory Affairs. From there, she moved to Integra LifeSciences for almost 11 years, most recently as VP of Quality Management Systems and Post-Market, before joining QualityHub.
“There’s a layer of practicality and reality that industry experience brings.” – Melinda Novatny
“I was always the one writing communications to the FDA [US Food and Drug Administration]. I was always the one developing strategy in the inspection ‘back room,’ no matter what my actual title was,” she said. “That’s just where I kept ending up.”
At Philips, she ran a regulatory group and helped consolidate a scattered organization into a single, functioning division with streamlined processes and regulatory strategies that met go-to-market timelines. At Integra, she worked in corporate on mergers and acquisitions, leading quality and regulatory due diligence on incoming deals. Both roles taught her a lesson she carries into every client engagement now: a system that looks compliant on paper and a system that actually works on the floor aren’t always the same thing.
“I remember visiting a manufacturing site during an integration and asking if the team used the corporate quality process everyone was so proud of,” she said. “They told me they couldn’t. They said it looked great in an audit, but nobody could actually follow it because it was too complicated.”
Novatny went on: “That’s what I think someone like me brings to a project. When I was in industry, I walked the shop floor every chance I had. I wanted to understand how a decision made in the office actually affected the way a product was built.”
Long before she joined QualityHub, Novatny knew the Orlando, Florida, consultancy from the other side of the table. As a client working alongside members of the team, she came away impressed by how QHub experts approached problems.
“I kept thinking to myself, ‘these people get it,’” she said. “That stuck with me.”
‘A Layer of Practicality and Reality’
Ask Novatny what a career built in industry brings to a consulting role that a career regulator might not, and she doesn’t hesitate.
“There’s a layer of practicality and reality that industry experience brings,” she said. “You develop a comfort with failure, because you can’t just hand someone a perfect textbook solution. People are a variable. Culture is a variable. Even the best-designed system in the world runs into that eventually.”
She’s also spent enough time inside quality organizations to know that culture matters just as much as documentation.
“It’s not only what’s written in your quality system,” Novatny said. “It’s whether people feel safe speaking up, or whether they’re just doing their job because that’s what’s on the page. Understanding that difference, and finding ways to relate to a client wherever they actually are, is incredibly important.”
Founded in 2004 on the principles of quality and a commitment to continuous improvement, QualityHub provides support in an array of technical areas, including product and quality systems development, auditing, complaint handling, supplier control, clinical compliance, training, and much more. Discover what QualityHub’s compliance consultants, project managers, and regulation experts can do for your company today.
