RegDesk’s Director of Regulatory Affairs, Jodi Frasier, shares 36 years of lessons on why RA gets invited too late, what executives actually want to hear, and 5 things every regulatory professional should do tomorrow to earn strategic influence.
Quick answer: Regulatory Affairs earns a seat in the boardroom by shifting from an approval checkpoint to a strategic business partner, joining projects at ideation instead of at submission, translating regulatory updates into revenue and timeline impact, and reporting business outcomes (launches enabled, revenue accelerated, cycle time) instead of just activity counts (submissions, approvals, deficiencies).
Watch the full webinar
This recap only scratches the surface of the real-world examples, Q&A, and tactical advice shared in the full session. If you want the complete conversation, including audience questions on balancing compliance with business partnership and improving RA’s relationship with R&D watch the full webinar replay here:
What stood out most is that these changes are not isolated developments. They are part of a broader transformation in how regulatory authorities think about traceability, transparency, and post-market control.
For manufacturers, this shifts the conversation away from managing individual country requirements and toward building a scalable regulatory strategy that can adapt across multiple markets.
The problem: RA is treated as the last stop, not a strategic partner
If you work in medical device or IVD regulatory affairs, this will sound familiar: your team gets pulled in right before submission and asked three questions.
- Can we submit?
- Is this compliant?
- What documentation is missing?
I’ve spent over 36 years in quality and regulatory leadership across the medical device and IVD industry, and here’s what I want you to hear first: most organizations aren’t purposely saying, “Let’s leave Regulatory Affairs out until the end.” It’s really not their intent to treat you as the final stop. Especially in less mature organizations, they simply don’t understand where Regulatory creates business value, so they treat this as an approval checkpoint instead of a design partner.
That gap shows up in familiar phrases across the org chart:
| What people say | What it actually means |
|---|---|
| “Regulatory will review before submission.” | RA is viewed as an approval checkpoint, not a design input. |
| “Engineering already made the decision.” | RA isn’t influencing product decisions. |
| “Marketing promised this launch date.” | Commercial commitments are made without regulatory input. |
| “We’ll fix labeling later.” | Regulatory requirements weren’t built into product strategy. |
The real cost of late regulatory involvement
I have lived these consequences, not just heard about them:
- FDA rejected biocompatibility data because the justification for waiving testing wasn’t adequate.
- Labeling required additional translations post-launch, forcing packaging and stability testing to be repeated on the corrected in-box IFU.
- Software architecture changed after a cybersecurity review, sending the review back to square one.
- MDR evidence gaps surfaced after design freeze, requiring costly retroactive testing.
I’ll give you a concrete example on that last point: if you’re planning to submit in the U.S. first, you can often get away with an electronic IFU. But not every market accepts that, many require a paper-in-the-box IFU with multiple translations. If all your shipping, transportation, and sterilization testing was validated with samples that didn’t include that heavier, multi-language physical insert, you may have to go back and retest everything. I’ve seen entire packaging configurations have to be completely redesigned to accommodate a global IFU.
Lost time to approval equals lost revenue. Delayed launches, duplicated work, unnecessary cost, avoidable redesign, missed business goals, this isn’t a compliance problem anymore. It’s a business strategy problem.
The mindset shift: from approval checkpoint to strategic partner
The fix isn’t a new process or a new title. It’s a mindset shift, both for Regulatory Affairs professionals and for the organizations around them.
| Traditional RA | Strategic RA |
|---|---|
| Reviews work | Shapes work |
| Approves submissions | Influences portfolio decisions |
| Tracks compliance | Enables business strategy |
| Reports activities | Reports business impact |
| Joins late | Participates from ideation |
When Regulatory is treated as a strategic partner, the questions it fields change entirely, from “What does Regulatory do?” to “What business decisions should Regulatory influence?”
Here’s where I have seen that influence pay off directly:
- Which products enter the portfolio- We can contribute a feasibility assessment, do you have an adequate predicate device, can you show safety and efficacy across your target markets, before the company commits.
- Which countries launch first– Regulatory sequencing is critical, and commercial teams especially need to understand this. Just because you have U.S. approval doesn’t mean you can automatically start registrations elsewhere. If you’re a U.S. manufacturer, that U.S. approval is often a gating item for entry into rest-of-world markets, because you need a Certificate to Foreign Government (CFG) as part of your registration package in many countries. There are markets where you’re excluded from even submitting until you have that document in hand.
- Acquisition due diligence– If you’re acquiring a company, I want someone from Regulatory in that room. Even if their products are cleared and on the market, you need to look at their evidence, not just the submissions and approvals on file, but what changes they’ve made to the product since. Are there hidden regulatory risks? You want to know before the acquisition decision is made, or you may be inheriting regulatory liabilities that are hiding in the background.
- Product roadmap– The companies I’ve worked with that get their roadmap strategy right bring Regulatory in to watch global trends and flag how they’ll affect the roadmap. AI-enabled medical devices are the clearest example right now, the regulatory landscape governing AI technology is moving fast, and understanding that trend can significantly change your roadmap timeframe.
- Clinical investment, technology selection, and manufacturing changes– All of these carry regulatory consequences that are far cheaper to plan for up front than to fix later. Manufacturing changes especially- I’ve seen companies forced into a supplier change for a critical component, and if you haven’t mapped the regulatory impact across every market where you currently sell, you end up scrambling to build a rollout plan just to keep customers supplied
What executive leadership actually needs from Regulatory
Here’s the reframe I think matters most: most RA teams report activity. Executives need business impact.
Don’t say: “We received three deficiencies.” Say instead: “This introduces an estimated eight-week launch delay for Product X, which impacts projected revenue in Germany.”
Right now, a lot of us report out on very simple metrics, approvals received, deficiencies that came in, submission status, risks. Those aren’t wrong, but they’re not enough on their own. Current metrics like submissions, approvals, deficiencies, and audits measure activity, not impact.
Strategic metrics I’d encourage every RA leader to start tracking and reporting:
- Revenue accelerated
- Launches enabled
- Countries opened
- Regulatory cycle time
- Time-to-commercialization
- Portfolio risk reduction
- Regulatory forecast accuracy
- Approval predictability
- Evidence reuse across markets
- Percentage of first-cycle approvals
Stop measuring activity. Start measuring business outcomes.
Communication: Regulatory speaks many languages
One thing I’ve learned over the years: the same regulatory update needs to land differently depending on who’s hearing it.
- Executive leadership cares about business risk, time-to-market, market access, and ROI. Talk about launch timelines and revenue impact, not annex numbers.
- R&D cares about technical feasibility and avoiding rework. Talk about how design decisions carry regulatory implications and what evidence needs to be generated.
- Quality cares about compliance and audit readiness. Talk about applicable standards, documentation, and objective evidence.
- Commercial cares about launch success and market expansion. Talk about launch timing, labeling implications, and country-specific considerations.
The throughline is the same in every conversation: translate regulatory detail into what that audience is already accountable for.
Credibility is the price of admission for influence
Strategic influence doesn’t come from opinion, it comes from evidence.
- ❌ Don’t: “I don’t think we should…”
- ✅ Do: “According to MDR Annex VIII…” / “Based on FDA guidance…” / “The notified body has historically interpreted this requirement as…”
I hold a strong belief that no one in Regulatory should be doing things they feel are out of compliance. You should never sign a document you don’t agree with or feel comfortable with. But agreeing to disagree isn’t enough — you have to educate the people you’re working with. If you think something isn’t compliant, you need to be able to pull the evidence, the standards, the regulation, and explain why. It’s not about giving yes-or-no answers. It’s about defining the risk, defining a path forward to mitigate it, and getting everyone aligned.
That same principle is what builds a real relationship with R&D. Teams that struggle with R&D usually aren’t bringing that kind of value to the table, so people start “regulatory shopping,” going around until they find someone in the organization who’ll give them the answer they want. Speaking from a documented, defensible position is what earns you a seat at the table instead of a workaround.
Five things every RA professional should do tomorrow
Frasier closed with a concrete call to action:
- Learn your company’s commercial strategy. You can’t influence business decisions you don’t understand.
- Quantify regulatory recommendations in business terms. Translate deficiencies and timelines into revenue and launch impact.
- Join projects before requirements are written. Early involvement,during feasibility, not at submission, is where we prevent costly rework. And make sure it’s the right person joining early: you need someone with a seasoned regulatory background to provide meaningful early guidance, not necessarily an entry-level associate who’s better suited to writing the submission later.
- Present options, not just regulatory constraints. Give stakeholders paths forward, not just blockers.
- Measure business impact, not regulatory activity. Report launches enabled and revenue accelerated, not just submissions filed.
If I had to leave you with one takeaway, it’s this: understand the value Regulatory adds to your organization’s business objectives and commercial success. You are not selling, and you are not adding to the bottom line directly, but the work directly influences it. If you do your job well, you help increase revenue. If you don’t, you take away from it. Understanding that, and thinking about how you personally can influence it inside your organization, is the biggest mindset shift I hope people walk away with
FAQ: Regulatory Affairs and business strategy
Why does Regulatory Affairs get involved too late in product development?
Most organizations don’t exclude RA on purpose, they simply don’t recognize where regulatory expertise creates business value, so RA is treated as a final review step rather than an early design input.
What’s the biggest mindset shift RA needs to make?
Moving from reviewing and approving work to shaping it, and from reporting regulatory activity (submissions, approvals, deficiencies) to reporting business impact (revenue accelerated, launches enabled, cycle time).
How should Regulatory Affairs communicate with executives?
By translating regulatory information into business outcomes, for example, converting “we received three deficiencies” into “this creates an estimated eight-week launch delay affecting projected revenue in a specific market.”
Can small regulatory teams become more strategic with limited resources?
Yes. Frasier recommends leaning on RIM platforms or service providers for regulatory monitoring so the team spends less time filtering noise and more time on strategic analysis, plus streamlining internal processes to free up capacity.
Should Regulatory Affairs own regulatory intelligence?
RA should own the initial triage and monitoring of regulatory intelligence, but changes that affect other functions, like a new quality management system requirement, need to be routed to the teams that own that work
