Top Talent Accelerant

Another conversation this week with a VP/hiring manager with a critical position completely out of alignment with the marketplace. Over 1,500 resumes and not seeing the talent they need.

This particular role I have successfully supported over 20 times, so I understood not only the technical skills he desired but also the strategic reason for the position and how much the hire would impact the business over the next 6 months to a year as the company continued to scale.

I asked him why a couple of candidate profiles weren’t an option, he paused and said, “Well, I guess part of the problem is I am trying to fill two positions in one. I’d like them to help us scale up in automation and controls, but it would also be nice if they could support certain manufacturing projects or do program management.”

“Yes, that creates a challenge.”

I asked him about two other candidates that were spot on for the “main role” he was trying to fill. His response: “Well, they are too expensive and experienced really.”

I nodded, understanding completely because I have had this conversation weekly for years now.

How is a hiring manager going to get someone that has the skills to fill two positions with 3-5 years of experience or less while paying at or below the market for the talent?

With automation and controls, scaling up a business, creating efficiency…. One mistake can cost an organization significantly. What are the consequences of getting this hire wrong? Saving thousands could end up costing millions.

Misalignment in the marketplace is a significant drain on resources. While the cost of a mishire is significant…. spending time and resources to curate resumes for a role that is out of alignment means the role will stay open for months. Understanding what candidates are making in the market in real time versus older compensation data is critical.

What is the opportunity cost?

How does it effect revenue timelines?

What is cost relevant to risk management for wasted resources, warning letters, or patient safety?

Companies must invest in resources internally or partner with those resources externally to understand what they need a person to do in a position, how that role can change over the next 6-12 months, and have real time data on what it will cost to hire the right talent.

The Pareto Principle is undefeated.

Leadership must understand the skill/position that they need to hire for, what that skillset costs in the marketplace, and understand that they will pay for what they need proactively while having a search process that is in alignment…

Or they will pay on the backend. The backend tends to be a lot more expensive in more ways than one.

I continue to consistently have conversations around the market dynamics and challenges of filling critical positions. Positions in RA/QA/Clinical that have been open 3-6 months.

What does this mean relevant to opportunity cost?
What does this mean relevant to wasted resources?
How does the additional work affect the rest of the team during this time?
What are the chances of a valuable team member is recruited away during that time?

According to the Department of Health and Human Services there is a regulatory vacancy crisis currently at the FDA with 16% of drug manufacturing inspector positions vacant.

40% open vacancy rate for infant formula inspectors and 20% vacancy for human food inspection.

Medtech companies are facing massive backlogs for De Novo and Breakthrough Device Designations. This has led to greater pressure on the marketplace as recruitment for RA talent has increased.

Some of the steepest challenges for recruitment are in the areas of:

Clinical AI Product Managers & Algorithm Engineers
Cybersecurity Specialists
Regulatory & Quality Leadership

Why?

1. The Macro Deficit: Workload vs. Talent Supply
The fundamental reason RA/QA positions are staying open so long is a sheer mathematical mismatch between regulatory volume and available humans.

2. The Global Workload Gap: The global Medical Device Regulatory Affairs market is expanding at a rapid 10.52% CAGR. However, the global talent pool—tracked by memberships in organizations like the Regulatory Affairs Professionals Society (RAPS)—only grew by 3.1%.

The Result: The volume of compliance work, driven by rolling global frameworks, is outpacing the creation of qualified compliance professionals by nearly 3-to-1.

Average time to fill for RA/QA leadership positions is reportedly over 3 months while RA/QA roles that involve AI, ML, and cybersecurity are taking 6-9 months to fill.

The core drivers keeping roles open longer are the increased demand for SaMD talent driven by the EU AI Act and the FDA-EMA joint AI guiding principle, the additional PMS burden, and nearshoring structural friction. The PMS burden is making it more challenging to find supplier quality and compliance auditing talent that understands the complex tracking required for connected/IoT medical devices.

This has led to greater misalignment for companies in recruitment strategy relevant to the actual market dynamics. If companies don’t invest internally or externally to improve recruitment strategies, ultimately, companies will wait longer to fill open roles and must adjust accordingly relevant to risk management, team alignment, and opportunity cost.

Data collected from- Medical Device and Diagnostic Industry, Medical Technology jobs, Mordor Intelligence, Panda International, & KiTalent

These are the strategic conversations and market analysis that I love the most!

In today’s medical device landscape, Regulatory Affairs Leadership talent can be extremely challenging, depending on the market and if the requirement is onsite or hybrid.

I recently had the opportunity to share data for a Senior Director of RA position for a partner whose position has been open for 5 months. Understanding the market, the relevant talent pool, and picking the right talent management strategy are vitally important.

This VP of RA shared that he wasn't seeing relevant candidates. After a review of the job responsibilities, the market, and doing some due diligence, I was able to share some vital information with the executive team.

Based on the skills they desired, there were roughly 77 RA professionals with relevant RA leadership experience — and far fewer who also bring the hands‑on depth experience they wanted across compliance systems, labeling, quality support, and the ability to be on-site three days a week.

Here’s how the talent pool looked:
VP / Consultant: 33
Associate Director–Sr. Director: 23
Manager–Sr. Manager: 21
Principal / Staff: 15

A targeted LinkedIn Recruiter search across RA leadership titles yields only ~29 candidates in that geographical area. The company was using multiple recruiting firms in a contingent shotgun approach, and most relevant candidates had already been approached multiple times. Four candidates in current director-level roles had applied and been auto-rejected by their internal systems.

Even candidates with highly relevant backgrounds — including one who previously performed this exact role and another with strong VP‑level endorsements — ultimately did not progress past their internal HR screening process to interview with the VP.

I shared the data, the conversations I had with candidates in the marketplace, and that at this stage, the challenge wasn't sourcing more names. It was achieving alignment with the recruitment team on what “right” truly looks like within a highly saturated, repeatedly tapped, and geographically constrained market.

I love the opportunity to talk with leaders about what matters to the company's success versus simply "filling a role"!

Hiring the right talent is so important, but knowing why you are filling the role, how the role can evolve, and ensuring the recruitment strategy aligns with the talent in the market are critical. Otherwise, a company can waste time and resources and hurt its image as well.

Two of my favorite things are partner site visits and meeting with candidates and hiring managers that I have worked with.

In the AGE of AI… people matter! Relationships matter…..

On a site visit, most of the employees don’t know who you are or why you are there. Are they smiling, collaborating…. What is the energy in the design area, manufacturing floor, or walking through the executive offices?

You cannot fake energy….. If you are paying attention to it, you can feel it as soon as you walk in the building. I love to be able to tell candidates about my personal interactions and what I have witnessed when doing a visit, as well.

Our new partner Lithionics has an impressive energy! As Mario Simoes led us through our site tour, Justin looked at me and said, “Man, everyone is so happy and nice here.” The memorial to the Missing Soldier as we walked in touched me.

Justin Bushko is another great example of a giver. He’s always looking to connect people, make introductions, and twice on the visit after hearing about a challenge or potential opportunity at the company, he said, “Hey, I know a great person that I need to connect you with that could help in that area.” We have been partnering and supporting each other for over 4 years. He’s not only amazing at what he does, but anyone that works with him knows they can trust him.

We finish the hiring manager content today for the TTA-Candidate Experience and away we go! Every candidate being attracted, vetted, and validated up front while getting to see a unique picture of the company, insight into their culture, what matters to them, and what the hiring manager is like and the key skills they need.

The hiring and manager and interview team get to see the candidate in a robust fashion that includes video, writing samples, personality profile, and their personal WHY along with what they are looking for.

Optimization of time, resources, and the ability to attract talent in a more efficient manner all while creating an Exceptional Candidate and Hiring Manager Experience!

I never in a million years thought I would be a recruiter, and I will be forever grateful for the journey that led me here, because I absolutely love the people I get to meet and partnering to help companies hire Top Talent.

In this conversation, we go beyond traditional hiring discussions and take a deeper look at how systems, leadership, and quality impact long-term organizational performance in MedTech.

Joe shares insights from helping companies stay inspection-ready at all times while building pragmatic quality systems that support sustainable business growth.

We also discuss:
* Why hiring cannot be separated from systems
* The hidden risks of misalignment in leadership and talent
* How quality culture impacts ex*****on
* And why strong teams are built through intentional structure, not just technical skill

If you’re in MedTech, leadership, quality, or talent strategy, this episode offers valuable perspective on building organisations that can scale with clarity and consistency.

Watch the full episode now.
https://youtu.be/FZKokGG3Yyc

Top Talent Accelerant Executive Why Great Hires Still Fail