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Updated September 30, 2021

Don't Hire Senior Regulatory Affairs People

Dr. Oliver Eidel

So you’ve founded your fancy new medical software startup and realized you’re developing a Medical Device. Great! You’ve also realized that regulatory compliance includes lots of work. But - what work exactly? You don’t really know.

Doesn’t matter though, because you’re a founder. You can delegate stuff. Someone else can take care of this mess.

Here are your options:

  1. You hire someone who has a lot of regulatory experience.
  2. You convince an existing team member to give up his / her role and to work on regulatory compliance instead.
  3. You hire someone who doesn’t have a lot of regulatory experience and train him / her.

Let’s discuss those. But before we do that, let’s put some more thought into the problem you’re trying to solve.

What Problems Do You Need to Solve?

You can dissect this problem into two parts:

  1. Your company needs to acquire regulatory knowledge.
  2. Someone needs to take care of regulatory work.

That triggers the next question: Can these two problems be solved by hiring one person? Let’s see.

1. Hire a Senior Regulatory Person

Hiring a senior regulatory person is the most obvious approach. You don’t have any regulatory knowledge and you need someone who will do the work, so why not hire someone who does both?

I’ve met quite a few senior regulatory affairs people who joined startups. They typically come from enterprise backgrounds. So far, it never worked out well.

Why? I don’t know. I don’t know what goes on in enterprise companies; I’ve worked with startups all my life. I do have some thoughts.

What’s the highest priority in startups? It’s shipping things fast. Why? You need customer feedback, have to achieve product-market fit and generate revenue. Those are serious problems to work on. An enterprise has already worked those out and has enough cash in the bank to work on less business-critical aspects. So nobody will complain much if the 20-person in-house regulatory team wanders off to work on unproductive activities, like doing internal audits, complicating processes and starting political fights.

However, a regulatory person at a startup has very different priorities. What is needed at there? Pragmatic solutions to tricky problems which carefully weigh regulatory risks with business risk (i.e., startup fails). Not only that, the regulatory person has to do this as a one-man (woman) show: There’s no 20-person team of in-house regulatory people to back them up. It’s just them, working with their startup. And they have to get things done, fast. There’s no time for re-discussing the hiring process with the CEO for the fifth time.

I’ve never seen senior regulatory people achieve that. Maybe they were never exposed to the pressures a startup faces. Or enterprise politics and isolation made them lose their pragmatism. I don’t know.

I’d be happy to be proven wrong and learn more. Feel free to introduce me to senior regulatory people at startups who succeeded.

2. A Team Member Relinquishes Their Role and Does Regulatory Work

Thinking back to the two parts of your problem, you tried to solve both by hiring a senior person. Maybe you should solve those two problems separately?

The first problem, acquiring knowledge, is tricky: Medical Device certification knowledge is a mostly-well-kept secret of expensive consultants. At least until this website is done. For now, your most realistic option is to bring in consultants.

The second problem, finding someone who does the work, is easier to solve: Someone from your team could do it. Unfortunately, that person will have to give up most of his/her current work, but you could hire someone for that. Hiring business people or coders is often easier than hiring good regulatory people.

Selecting consultants and working with them is an entirely different topic, but your goal should be to gain as much knowledge as possible to become self-reliant in the future.

Most startups don’t notice that this approach has some really nice properties: The person in your team dealing with regulatory work is often one of the founders or early employees. So they have deep knowledge of the company and product. And they have authority because they’re part of the “early joiners”. Both of these things are extremely beneficial for moving through the regulatory process fast.

And guess what? After that person has done the job for some time, it’ll be much easier to hire people because now you know what to select for.

This however assumes that someone in your team is willing to dive into regulatory work. That’s often another problem: The mental burden of regulatory work can range from boring to mind-numbing. And especially for logically-inclined people like software developers, it’s near-impossible to work in this area for a long period of time. That leads us to the final option.

3. Hire a Junior Person

This is very similar to the preceding approach, except that you hire someone new to take care of the work.

The newly-hired person will have a hard time: They don’t have knowledge of the company / product, and they don’t have any authority in the company. So you have to bring them up to speed quickly and ensure that they gain the authority which is necessary for getting regulatory compliance done.

I would only recommend this if no one in your team is willing do take over regulatory work. But then, ironically, this approach could be very beneficial: If you manage to find someone who is both interested in regulatory work and finds pragmatic solutions, then you have a winner.

Wrap-up

Aim for someone in your team to do this and fully support them in acquiring the necessary knowledge. If you don’t have a person in your team who is interested enough in regulatory work, hire someone who is. Prioritise pragmatism over regulatory knowledge.

This table sums it up:

  Senior Hire Team Member Junior Hire
Knowledge x    
Interest   (x) x
Pragmatism   x x
Recommended? No Yes Yes

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I work as a regulatory consultant for Healthcare software startups. I try to publish all my knowledge here so that startups can certify their medical devices themselves in the future.

If you're still lost and have further questions, just send me an email and I'll be happy to answer them for free. More about me

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