Head of Regulatory Affairs

Head of Regulatory Affairs - Medtech Start-Up - FDA

This is a Head of Regulatory position at a Danish Medtech start-up with a product that could become the first-of-its-kind on the market if given regulatory approval. This is also why they have opened this position as their first in-house Regulatory role, with the aim for this person to also build a team over time (2-4 additional colleagues).
Whilst we cannot disclose the exact product here, it is a brand-new type of product within the obesity and diabetes sphere, promising a different technology compared to traditional methods and is an area where consumer electronics companies have spent loads of money to stay relevant in a world with increasing obesity rates (and this product would partner nicely with them).
So all in all, this would be a very hands-on position but with the opportunity to drive regulatory strategy and have a massive impact internally. Not to say the opportunity to be the first person to get this type of product past the FDA.
Your main focus in this role would be towards gaining FDA approval. It is a highly advanced Class II device so there are several challenges around simply getting regulators to understand the internal workings and what “boxes” needs to be checked.
A lot of groundwork has already been made though, including multiple pre-submissions, meaning you won’t start from scratch and without available feedback. However, approval is not imminent and plenty of development and prototyping work is still taking place to get the final design.
Another key to this position is the availability to take late meetings in the evenings, as well as flexibility to travel (if and when it is needed). This is a natural result of the role being FDA oriented and the company having established local regulatory partnerships in US to help facilitate the process.
Location:
Copenhagen or Fyn ( Ideally hybrid - at least 3 days on-site per week)
We are also open for relocators from the EU or even considering someone based remote abroad if your profile fits in really well.

Requirements

• Significant experience in medical device regulatory affairs, especially with FDA pathways for Class II or higher devices. Having been through multiple successful (and potentially unsuccessful) approval processes in the past is needed.
• Direct experience with 510(k) and De Novo submissions, and interaction with FDA reviewers.
• Degree in Life Sciences, Engineering, Pharmacy, or a related field.
• Familiarity with devices involving embedded software would be a plus.
• Fluent in English.

Curious to learn more?
If this sounds like the challenge for you, then feel free to reach out to Anders Sandberg at Black Swans Exist (Recruitment Partner for this position) or simply apply to this advert with an attached CV (does not need to be fully updated, we can deal with that later. The process will be entirely confidential and we only present you to the end-client after having had an introductory meeting to see if it is that right role for you.