Lavanya Ramnath

Success for Lavanya is the result of incredible leaders who invested in her, and her own deliberate choices to build depth over everything else.

The People Who Believed First

Leaders who took real risks on her: At Abbott, a leader saw her potential and gave her ownership of a major EU MDR new product development project — something not commonly given to someone at her level in that organization. Rather than having her support while they took the work and the credit in rooms with executives and regulators, they invested in her development and gave her the platform.

Early in her Abbott role, another leader trusted her to present directly to the Notified Body scheme manager less than two months into the position. They could have kept her in a supporting role, extracted the work from her, and presented the strategy themselves. Instead, they created the opportunity for her to build credibility with regulators directly.

A mentor who opened doors instead of closing them: A dear mentor offered mentorship during what could have been a closed door - a missed job opportunity on her team. Instead of that ending things, she opened many doors for Lavanya's career. That kind of generosity stays with you.

These weren't people who gave her easy tasks. They gave her stretch opportunities before she even thought she was ready. And they backed her up behind the scenes while letting her lead in the rooms that mattered.

Depth Over Everything Else

She came to the US 45 days after graduating with her bachelor's degree from India. Visa constraints were real. She couldn't work a traditional job in that first year. So she volunteered at hospitals and labs associated with USC to learn US work culture and build experience. She took classes in regulatory affairs at USC. She built on that foundation with an internship at Micro Medical Devices in Calabasas. Then another opportunity at the Regulatory Science Consulting Center at USC. She completed a research dissertation on combination devices as part of her regulatory science program.

This wasn't a shortcut path. This was someone deliberately building foundational knowledge, one unglamorous experience at a time. She wasn't waiting for the perfect job. She was learning the field from the ground up.

That foundation of depth - understanding not just what regulations say but why they exist, how they've been interpreted, what the grey areas are is what makes her judgment valuable now.

Credibility Through Risk-Based Thinking

She treats credibility like her life depends on it. Because in medical devices, it does.

This means her guidance is based on genuine risk-based evaluation. She doesn't just follow regulations ; she understands them deeply enough to evaluate which parts apply to a specific device, which grey areas exist, and which parts can be handled with documented risk-based rationale. She knows the difference between compliance and understanding.

She would rather say "I need to look into this further or discuss with the team before I give you an answer" than provide a confident response that turns out to be incorrect. That habit costs time in the moment but builds trust over years. In regulatory affairs, you build credibility over years. Every guidance she gives, every submission she prepares, every interaction with regulators — she protects that currency with intellectual integrity and risk-based thinking.

Lesson #1: "Be so solid in your work that someone's criticism says more about them than about you."

Her mentor asked her early on: "As you grow in your career, what is one thing you want to achieve?"

She answered in titles and milestones — bigger roles, leading complex programs, successful submissions.

The response that changed everything: Be so solid in your work that someone's criticism says more about them than about you.

That line reframed how she thinks about growth entirely. She realized careers are not built on big moments. They are built on consistency, attention to detail, and the habit of doing the work well even when no one is watching. And sometimes, that is exactly what leads to the big moments. Over time, she has learned that this principle protects you in ways that defensive behavior never can. When you are genuinely solid in your work, you do not have to fight for recognition. You do not have to overstate your role. You do not have to worry about people taking credit. The work speaks, and people who need to see it, see it.

Lesson #2: "Knowledge only becomes valuable when you share it."

Same mentor, same conversation: If you don't speak up and don't bring others along with you, the work stays with you — but the impact doesn't.

This one hit differently because she is naturally someone who prefers to work quietly. But regulatory affairs is not a solo sport. She sits at the center of cross-functional teams. Her job is to help engineers, clinicians, product people, business leaders all understand the regulatory landscape in a way that helps them make better decisions.

She learned that being effective in regulatory does not mean knowing all the answers. It means:

• Being clear about what you know and do not know
• Explaining your thinking so others can follow
• Teaching privately, then creating space for others to shine publicly
• Helping the team move forward, not just having the right answer in your head

This advice became the foundation for how she approaches mentorship too. The most valuable thing she can give someone entering this field is not information — it is judgment. It is showing them how to think about problems, not just what to think.

Lesson #3: "Respond to situations; don't react to them."

It sounds simple, but it has changed how she handles difficult conversations, feedback she disagrees with, and moments when she wants to defend herself.

Reacting = clicking on someone's bait. Handing them exactly what they were fishing for.

Responding = choosing silence, staying consistent with your standards, letting your work speak, staying in your own narrative rather than getting pulled into someone else's.

She has learned that the best response often is not a long explanation or debate. It is:

• Silence (when the situation does not warrant engagement)
• Doing your best whether someone is watching or not
• Staying consistent
• Letting time and life run its course

Your peace is more valuable than being right in someone else's narrative. That advice has saved her so much energy and protected so much credibility.

Lesson #4: "Your company should grow you, but you own your trajectory."

You can learn from your current role, but do not wait for the perfect role to land in your lap. Identify the skills you need next, find ways to build them — through stretch assignments, through volunteer leadership, through being curious about problems outside your immediate scope. Be grateful for your current role and be intentional about what is next. Do not confuse loyalty with stagnation.

1. Don't accept the "nice girl" narrative.

Women will be told (sometimes directly, sometimes indirectly) that if they are too direct, too vocal they are "difficult" or "trying very hard to prove themselves". That if they ask detailed questions, they are being picky. That if they push back on a regulatory decision, they are not a team player. Ignore that. Being direct, exacting, and precise is not a personality flaw in regulatory affairs and healthcare in general. It is a job requirement. The job is to help ensure that products reaching patients are safe. That requires asking hard questions. That requires being willing to say "this does not meet our standards" even when it is uncomfortable. Women can do that while being respectful and collaborative. And they should. But do not shrink the core of the work to fit a more palatable persona.

2. Build expertise, not a reputation.

Early in her career, Lavanya worried that unless she could label herself a certain way, people would not take her seriously. She would see other people building personal brands, self-promoting, talking about their accomplishments loudly.

Then she realized: Expertise is not something you print in a headline. It is something you earn through work. The people who sought her out for regulatory guidance and technical writing were not doing so because of her title. They were doing so because she had actually helped them solve problems. Titles fade. Impact lasts. So, build your expertise by:

• Doing your actual job really well
• Staying curious about why regulations exist, not just what they require
• Building judgment (which only comes from seeing lots of different situations)
• Asking questions that make people rethink their assumptions
• Writing clearly enough that people actually understand your thinking

The visibility tends to follow.

3. Don't confuse credentials with credibility.

There is a lot of pressure to get certifications, take courses, get the fancy credentials. They can be valuable. But they are not a shortcut to expertise. Credential is a supplement to experience, not a replacement for it.

When building your expertise:

• Prioritize depth over breadth early on
• Seek roles where you will touch the full lifecycle of a submission, not just one small piece
• Ask to sit in conversations you are not officially part of so you can learn how decisions actually get made
• Build pattern recognition across different products and regulatory pathways

The unglamorous work of understanding details is where credibility actually comes from.

4. Find mentors, but be strategic about what you ask them.

Lavanya had mentors who taught her judgment. She had sponsors who gave her opportunities when no one else would. Those two things are different, and both matter.

A mentor teaches you how to think. A sponsor puts you in rooms where you can demonstrate that thinking.

When you are early in your career, you need both. But be strategic:

• Ask your mentor about judgment: "How would you approach this regulatory decision?" "What judgment calls are you making here?"
• Ask your sponsor for opportunity: "What would it take for me to lead this submission?" "How can I show you I am ready for the next level?"
• Ask your peers for operational help: "How does your company organize this process?" "What is the easiest way to do this that you have found?"

Not every senior person needs to be both mentor and sponsor. Distributed mentorship is okay.

5. Stay honest about what you know and don't know.

This is particularly important for women in technical fields because there is extra pressure to seem confident even when uncertain.

Lavanya has learned that the professionals people actually trust are the ones who are comfortable saying:

• "I do not know the answer to that, but let me find out."
• "I need to review the most recent guidance before I give you a confident answer."
• "That is outside my expertise, but here is who would know."

This is not weakness. It is integrity. And over time, people trust integrity far more than they trust confident wrong answers.

6. Build relationships across functions, not just within regulatory.

Regulatory affairs sits at the intersection of engineering, clinical, quality, product, business. The job is partly to translate between these worlds.

The best regulatory professionals she knows have genuine relationships with engineers, clinicians, and product leaders. They understand the why behind decisions from other functions. They can speak the language.

When building your expertise, spend time understanding:

• How engineers think about design and risk
• How clinicians think about clinical evidence
• How quality people think about manufacturing and risk management
• How product people think about competitive advantage and patient needs

That is where judgment comes from — understanding how all these pieces fit together.

7. Don't internalize the "bootstraps" narrative about career progression.

Lavanya talks a lot about working hard and earning credibility. That is real. But she also wants to be honest: She had advantages. She had people who believed in her. She did not face certain barriers that other women do.

If you are navigating visa sponsorship, childcare limitations, financial constraints, health issues, or any of the thousand other real barriers that exist — the fact that those are harder does not mean you are less capable. It means the system is harder.Be honest about what you need. Seek out companies and leaders who will support you, not judge you. And remember that taking the path that works for your life — even if it is different from someone else's path — is not a failure.

8. The most important thing: Know your "why."

For Lavanya, it started with her grandmother who did not have access to good diabetes management options and several relatives that suffered from heart diseases. It continues with knowing that the work she does helps shape treatments that reach millions of patients.

That "why" is what keeps her going when the regulatory landscape is frustrating, when she is tired of writing technical documentation, when she feels like she is in the same conversation she has had five times before.

Find your why. Is it helping patients? Is it solving complex problems? Is it mentoring others? Is it building something innovative? Is it the intellectual challenge?

Know it. Protect it. Come back to it when the job feels like just a job.

Because regulatory affairs is genuinely challenging, and the people who stick with it long term are the ones who know why they are doing it.

The Challenges:

1. The speed vs. safety paradox. Every company wants to move faster. Every regulator wants more evidence. And somehow, the regulatory affairs professional is supposed to thread that needle.

The real challenge is not speed or safety individually. It is that companies often treat regulatory strategy as something you figure out late — after the product is designed, after testing is done, as a "last mile" problem.

The result? Incomplete data, missing traceability, unclear stories that require additional review cycles. Which slows things down.

The solution is upstream, but it requires a culture shift that many organizations have not made yet.

2. The documentation vs. judging dilemma. Here is something Lavanya talks about a lot: In medical devices, if it is not documented, it did not happen.

But there is a real tension: Engineers are building innovative solutions. They are making judgment calls constantly. But the documentation of why they made those calls — the traceability from risk to control to testing — often lags behind.

This is not malicious. It is just that engineers are focused on solving the problem, not narrating the solve.

The challenge: Helping teams understand that documentation is not bureaucracy. It is the story that lets reviewers trust your decisions.

3. The shortage of experienced regulatory professionals. The field is growing faster than the pipeline can sustain. Companies are putting early-career professionals into high-responsibility roles without adequate mentorship. That is risky — both for the individuals (they get blamed for things outside their control) and for innovation (inexperienced reviewers of complex products).

The profession needs more mentorship infrastructure. Companies need to invest in growing talent, not just hiring it. The industry needs recognition that regulatory expertise takes years to build.

4. Regulatory fragmentation across geographies. FDA, EU MDR, UKCA, Australia, Canada, PMDA, CFDA, Health Brazil — the list goes on. Every region is moving at a different pace with different philosophies.

This creates real complexity for global companies. Some are solving it well. Many are not. And the cost of getting it wrong — either in terms of delay or in terms of compliance risk — is significant.

5. The SaMD and SiMD knowledge gap. Software in medical devices is evolving faster than regulatory frameworks. AI is entering submissions. Cybersecurity is becoming a core requirement.

Many regulatory professionals were trained in device-focused paradigms. Suddenly they are reviewing algorithms, software architectures, cybersecurity protocols. That is a massive knowledge gap, and the industry is racing to fill it.

The Opportunities:

1. Regulatory strategy as competitive advantage.

The companies winning long-term are the ones treating regulatory strategy as part of product strategy from day one. Not as a hurdle to clear at the end.

This is an opportunity for regulatory professionals to sit at the table earlier, to help shape the evidence plans, to architect submissions that reviewers actually want to read.

But it requires companies to value that seat at the table. Some do. Some do not yet.

2. Knowledge democratization.

There is so much regulatory expertise trapped in individual heads or locked away in company silos. Platforms, educational resources, mentorship networks — these are emerging ways to democratize that knowledge.

The opportunity: If the profession can make hands on regulatory knowledge more accessible, it can reduce the "learning curve by trial and error" phase. It can help more people enter the field. It can build a stronger profession.

3. Building regulatory expertise in emerging technologies.

AI, cybersecurity, real-world data, digital health — these are areas where regulatory guidance is still being written. There is an opportunity to help shape how these technologies get regulated.

The professionals who build expertise in these areas early — who understand the technology and the regulatory landscape — will be invaluable.

4. Mentorship and the next generation.

There is an opportunity to be intentional about growing the next generation of regulatory professionals. Not by pushing them through accelerated tracks that make them fragile, but by giving them solid foundational work, good mentorship, and the time to build real judgment.

5. International collaboration and learning.

The best regulatory professionals Lavanya knows do not just know their home region. They understand how different regions approach the same problems differently. That cross-pollination of ideas — learning from EU MDR's risk-based approach, from PMDA's evidence expectations, from Health Canada's pragmatism — makes you a better regulator of innovation everywhere.

Intellectual Integrity

This is non-negotiable. It means being honest about what she knows and does not know. It means not pretending certainty when uncertain. It means admitting mistakes quickly.

In regulatory affairs, intellectual integrity is particularly important because people are relying on her judgment to help make decisions that affect patient safety. There is no room for false confidence.

In personal life, it means the same thing: being honest with herself and others about what is true. Not performing a version of herself that she thinks is more likable.

Depth Over Appearances

She would rather do one thing really well than do ten things at a surface level. She would rather be useful to a small group of people who genuinely value her thinking than be visible to a large group who barely know what she does.

This shows up in how she chooses her work, how she mentors, how she spends her time. When she commits to something, she goes deep.

Clarity

She believes if she cannot explain something clearly, she does not understand it well enough. This drives a lot of her work — the way she writes submissions, the way she mentors, the way she communicates across functions.

Clarity is an act of respect. It says: Your time matters. She is not going to waste it with jargon or unclear thinking. She is going to do the work to make this understandable.

Generosity

Not just financial (though that matters). Generosity with knowledge, with time, with opportunity.

She spent years getting help from people who did not have to help her. That created an obligation — not to repay them (you cannot), but to pass that forward.

She believes in giving credit generously, in lifting people up publicly, in creating space for others to shine. That is the only way she knows to repay the people who lifted her.

Autonomy and Agency

She believes in her own ability to shape her life and career. She does not like waiting for permission. She does not like excuses.

But she also extends that belief to others. She believes in trusting people to make their own decisions. She believes in giving people the space and information they need and then stepping back.

This shows up in her mentorship (she asks questions; she does not prescribe). It shows up in her leadership (she sets expectations clearly; then she lets people figure out how to meet them).

Grounded Ambition

She is ambitious. She wants to do meaningful work. She wants to advance in her career. She wants to help shape the future of her field.

But it is grounded in why she is ambitious. It is not about titles or visibility. It is about impact.

When her ambition starts disconnecting from purpose, that is when she knows she needs to reset.

Patience with Progress

This one is hard for her, but she is learning it: Real expertise takes time. Real change takes time. Real relationship-building takes time.

There are no shortcuts to credibility. There are no hacks to judgment. You build them slowly, consistently, through unglamorous work that no one notices.

She is learning to be patient with that process — in herself and in others.

Comfort with Complexity (and Not Simplifying What's Complex)

So much of professional discourse is about simplifying things. Making them digestible. Reducing complexity.

But sometimes, complexity is real. Sometimes a decision is genuinely difficult because the tradeoffs are real.

She values being able to sit with that. To acknowledge that something is genuinely hard. That there are legitimate competing interests. That you might make the best decision available and it still might not be perfect.

That comfort with complexity is what allows for real judgment — as opposed to following rules or oversimplifying