Key Pre-Regulatory Roles Every MedTech Startup Needs

For MedTech founders navigating the pre-regulatory phase, building the right team is not just an HR exercise. It is a strategic imperative that directly impacts your timeline, investor confidence, and ultimately, patient access to your technology.

Every MedTech company is different. Your leadership needs will vary based on your regulatory pathway, technology type, clinical evidence requirements, and go-to-market strategy. A software-as-a-medical-device company will have different priorities than a Class III implantable, and a diagnostic platform faces different challenges than a surgical robot. The roles below represent the most common leadership positions we see driving regulatory success, but your specific situation may call for a different configuration or sequence.

With that context, here are the essential leadership roles that most pre-regulatory MedTech companies need, when to hire them, and what to look for in candidates who can actually deliver regulatory success.

Why Pre-Regulatory Hiring Is Different 

The pre-regulatory phase is uniquely demanding. You are not yet generating revenue, your product may still be evolving, and every month of delay costs runway. The executives you bring in must be comfortable with ambiguity, resourceful with limited budgets, and experienced enough to anticipate regulatory challenges before they become deal-breakers. 

Most critically, they need to have done it before. Regulatory leadership is not a role where you can afford on-the-job learning. The difference between a leader who has shepherded a device through 510(k) clearance versus one who has only supported submissions from the periphery can mean six months or more on your timeline. 

The Five Critical Pre-Regulatory Roles 

1. VP or Head of Regulatory Affairs 

When to hire: 12 to 18 months before your target submission date. Earlier for PMA pathways. 

This is your quarterback for regulatory strategy. In the pre-regulatory phase, this leader is not just preparing submissions. They are shaping your development roadmap to align with regulatory requirements from the outset. 

What distinguishes exceptional RA leaders in the pre-regulatory context: 

• Pathway expertise: Have they led submissions through your specific pathway (510(k), De Novo, PMA, CE under MDR)? Pathway experience is not transferable. 

• FDA relationship management: Do they have established relationships with FDA reviewers? Can they navigate pre-submission meetings effectively? 

• Cross-functional influence: Can they translate regulatory requirements into actionable guidance for engineering and clinical teams without creating bottlenecks? 

• Strategic foresight: Can they anticipate predicate device challenges, identify potential clinical evidence gaps, and flag manufacturing documentation issues before they delay your submission? 

Red flag to avoid: Candidates whose experience is primarily in large company regulatory departments where submissions are handed to them in near-final form. Pre-regulatory startups need builders, not reviewers. 

2. VP or Head of Quality Assurance 

When to hire: Before you finalise design controls. Ideally during late-stage prototyping. 

Quality and regulatory are often conflated, but they require distinct skill sets. Your QA leader establishes the systems and documentation that prove your device is manufactured consistently and safely. 

Critical capabilities for pre-regulatory QA leadership: 

• QMS architecture: Can they build a Quality Management System from scratch that is audit-ready but not bureaucratically paralysing for a small team? 

• Design history file expertise: Do they understand what FDA and Notified Bodies actually scrutinise in DHFs, and can they ensure documentation is generated correctly the first time? 

• Supplier qualification: Can they establish supplier controls that scale with your manufacturing needs without over-engineering for your current stage? 

• CAPA and risk management: Do they bring mature thinking about risk management (ISO 14971) and corrective action processes? 

The best pre-regulatory QA leaders have a pragmatic philosophy: build quality systems that meet regulatory requirements without creating documentation overhead that slows your team. This balance is difficult to achieve and requires genuine startup experience. 

3. VP or Head of Clinical Affairs 

When to hire: When clinical evidence is required for your submission pathway. Typically 18 to 24 months before submission. 

If your regulatory pathway requires clinical data, whether a pivotal trial, clinical performance study, or post-market clinical follow-up plan, your clinical affairs leader designs and executes the evidence generation strategy. 

What to prioritise in pre-regulatory clinical leadership: 

• Study design expertise: Have they designed studies that FDA or Notified Bodies have accepted? Can they right-size your clinical programme for your risk classification and intended claims? 

• Site management: Can they identify, qualify, and manage clinical sites effectively, including navigating the challenges of working with academic medical centres versus private practices? 

• Regulatory alignment: Do they work collaboratively with RA to ensure clinical endpoints align with submission requirements, or do they operate in a silo? 

• Budget discipline: Can they design clinically robust studies within startup budget constraints? 

A common mistake: hiring clinical operations expertise before clinical strategy expertise. You need someone who can define what evidence you need before you hire the team to generate it. 

4. VP of Engineering or R&D (with Regulatory Awareness) 

When to hire: From founding, but regulatory awareness becomes critical as you approach design freeze. 

Your technical leadership may already be in place, but as you enter the pre-regulatory phase, their role shifts. Design decisions now have direct regulatory implications. 

What pre-regulatory phase demands from engineering leadership: 

• Design control fluency: Do they understand and embrace design controls as a development discipline, not just a documentation burden? 

• Verification and validation planning: Can they plan V&V activities that generate the evidence regulatory reviewers require, integrated into your development timeline rather than bolted on at the end? 

• Manufacturing transfer readiness: Are they designing for manufacturability and thinking about process validation requirements? 

• Cross-functional collaboration: Can they work effectively with RA and QA without defensiveness or territorial behaviour? 

If your current engineering leadership views regulatory as an obstacle rather than a design input, you have a leadership misalignment that will cost you time and money. 

5. Chief Medical Officer or Medical Director 

When to hire: When clinical credibility and KOL relationships become strategic priorities. Often around Series A or when clinical studies begin. 

A CMO in a pre-regulatory MedTech company serves different functions than in a commercial organisation. At this stage, they are primarily focused on clinical strategy, physician engagement, and scientific credibility. 

Pre-regulatory CMO priorities: 

• Clinical advisory board development: Can they recruit and manage relationships with key opinion leaders who will champion your technology? 

• Clinical evidence strategy: Can they partner with clinical affairs to define clinically meaningful endpoints that resonate with both regulators and the physician community? 

• Scientific communication: Can they represent your technology credibly at medical conferences and in peer interactions? 

• Investor communication: Can they articulate clinical value and differentiation to investors during fundraising? 

For some pre-regulatory companies, a part-time or advisory CMO may be sufficient until commercial activities approach. The key is having clinical leadership engaged before you make irreversible decisions about your clinical evidence strategy. 

Building Your Pre-Regulatory Leadership Team 

The Hiring Sequence Matters 

For most MedTech startups, the optimal hiring sequence is: 

• First: VP Regulatory Affairs. They should inform your development roadmap from the earliest practical point. 

• Second: VP Quality Assurance. Quality systems need to be in place before you generate documentation you will submit. 

• Third: VP Clinical Affairs (if clinical evidence required). Clinical strategy should be defined before studies begin. 

• Fourth: CMO (as strategic priority dictates). Timing depends on your clinical and investor engagement needs. 

Your VP Engineering or R&D is likely already in place, but ensure they have or develop the regulatory awareness required for the pre-regulatory phase. 

Where Founders Go Wrong 

The most common pre-regulatory hiring mistakes we observe: 

• Hiring titles instead of track records: A VP Regulatory Affairs from a large company may have managed teams but never owned a submission end-to-end. 

• Waiting too long: Every month of delay in hiring regulatory leadership typically translates to more than a month of delay in your submission timeline. 

• Underestimating mission alignment: There's a difference between someone who believes your technology needs to be in doctors' hands and someone joining for the package. The latter rarely lasts through the hard parts. 

• Overlooking the RA/QA relationship: These leaders must work seamlessly together. Hiring them independently without considering team dynamics creates friction. 

The Bottom Line for MedTech Founders 

Your regulatory submission is not a milestone you prepare for in the final months. It is an outcome you build toward from the earliest stages of development. The leadership decisions you make in the pre-regulatory phase determine whether your path to market is measured in months or years. 

The executives who succeed in pre-regulatory environments share common traits: they have done it before, they are comfortable with ambiguity, they can build systems without over-engineering them, and they understand that in a startup, everyone is hands-on. 

Investing in the right pre-regulatory leadership is not an expense. It is the single highest-ROI decision you can make to protect your timeline and your investors' capital. 

If you're navigating these hiring decisions and want to talk through your specific situation, we're always happy to help. We've spent over 25 years placing MedTech executives across 40+ countries, so we've seen firsthand what works (and what doesn't) at every stage of the journey. Whether you're making your first leadership hire or strengthening your team ahead of submission, feel free to reach out at contact@gsmedtech.com.