Regulatory Radar – Understanding the forces shaping talent and transformation in biotech and medtech.

Hayley has nearly a decade of experience specialising in Regulatory Affairs recruitment, earning a strong reputation for placing exceptional Regulatory Affairs and Quality Assurance professionals across the US life sciences industry, from Associate to Head of level. She partners predominantly with Phase II and III biotech organisations, typically with fewer than 200 employees, collaborating closely with senior leadership to develop hiring strategies, refine role requirements, and optimise recruitment processes that deliver efficient, high-quality hiring outcomes.

Over the past month, the regulatory landscape has continued to evolve at pace. Conversations have centred around the future of FDA review processes, the increasing influence of AI within healthcare, and a hiring market that remains selective but resilient.

As someone who specialises in Regulatory Affairs recruitment, I spend my days speaking with regulatory leaders, founders, hiring managers and consultants across the East Coast US. Rather than summarising every industry headline, my aim is to highlight the developments that I believe will have the greatest impact on regulatory strategy, hiring decisions and business performance.

This month, here’s what’s on my radar.

What MDUFA VI could mean for MedTech

One of the most significant developments this month has been the publication of the FDA’s draft commitment letter for MDUFA VI (2028–2032). Although implementation is still some way off, the proposals offer a valuable insight into the FDA’s direction of travel and what medical device manufacturers should (or will) be preparing for over the coming years.

Key areas of focus include:

• Greater emphasis on early engagement between industry and the FDA.
• Continued development of review processes for digital health technologies and AI-enabled devices.
• Increased use of real-world evidence.
• Ongoing improvements to review performance and predictability.

For Regulatory Affairs teams proactive regulatory strategy is becoming increasingly important. Businesses that engage with regulators early, invest in robust submission planning and identify potential challenges before they become obstacles are likely to place themselves in a much stronger position.

Specialist Expertise continues to drive demand

While overall hiring remains measured, demand for specialist Regulatory Affairs professionals continues to hold up well.

The conversations I’ve had over the past month suggest companies are being far more targeted in where they invest. Rather than expanding teams across the board, they’re focusing on hires that will directly support key regulatory milestones and commercial objectives.

The strongest demand I’m currently seeing includes:

• FDA Regulatory Strategy
• Regulatory CMC
• Global Regulatory Affairs
• AI and Digital Health
• Software as a Medical Device (SaMD)
• Combination Products

Interestingly, I’m also seeing more organisations value candidates who have worked across both industry and regulatory consulting. The ability to adapt quickly, solve complex regulatory challenges and communicate effectively with multiple stakeholders is becoming increasingly attractive.

For candidates, technical expertise alone is no longer enough. Commercial awareness, influencing skills and cross-functional leadership are becoming just as important.

Growth is substantial on the East Coast, USA

Across the East Coast biotech market, businesses continue to balance growth ambitions with financial discipline.

Although restructuring activity remains part of the landscape, I’m also seeing increasing confidence from organisations approaching key clinical, regulatory and commercial milestones.

Rather than broad recruitment campaigns, hiring is becoming more focused and milestone-driven.

Companies are prioritising professionals who can:

• Lead complex FDA interactions.
• Strengthen regulatory strategy ahead of submissions.
• Build scalable regulatory processes.
• Support international expansion.
• Work effectively across Quality, Clinical and Commercial teams.

In my view, this reflects a growing recognition that Regulatory Affairs isn’t simply a compliance function — it’s a strategic capability that can directly influence business success

Looking ahead to the future of Regulatory Affairs

As we move into the final few months of 2026, these are the trends I’ll be watching most closely.

Earlier investment in Regulatory Affairs

More organisations are recognising the value of involving Regulatory Affairs earlier in product development, rather than bringing in expertise shortly before major submissions.

Continued demand for niche expertise

Competition for specialists in AI, Digital Health, SaMD, combination products and advanced therapies is unlikely to slow anytime soon.

A competitive candidate market

Whilst overall hiring remains selective, experienced Regulatory Affairs professionals continue to be in short supply.

For employers, speed of process, clear communication and a compelling opportunity will remain critical factors in securing first-choice candidates.

Based on what I’m seeing in the market today, here are my predictions for the months ahead:

• Demand will continue to grow for Regulatory Strategy, Regulatory CMC and Digital Health specialists as companies prepare for future submissions and commercial expansion.
• Expect more project-based hiring. Businesses will increasingly use interim and consultancy support to access specialist expertise while managing budgets carefully.
• Competition for experienced talent will remain strong. Candidates with proven FDA interaction, global submission and cross-functional leadership experience are likely to continue receiving multiple approaches.

One thing has become increasingly clear this year, and that is that organisations navigating uncertainty most successfully aren’t necessarily those with the biggest regulatory teams, they’re the ones with the clearest regulatory strategy.

Whether it’s evolving FDA expectations, advances in AI, or increasing competition for specialist talent, Regulatory Affairs is becoming more closely aligned with business strategy than ever before. From a recruitment perspective, I also believe we’re entering a market where quality will matter far more than quantity. The organisations that clearly define what they need, move decisively and position Regulatory Affairs as a strategic function will be the ones that attract and retain the strongest talent.

What does all this mean for those looking to hire in Regulatory Affairs?

If there is one clear takeaway from this month’s market activity, it’s that Regulatory Affairs continues to play an increasingly strategic role across biotech and medtech organisations.

Whether it’s navigating uncertainty around FDA review capacity, responding to the growing complexity of digital health regulation, or ensuring critical development milestones stay on track, regulatory expertise has become a genuine competitive advantage. The organisations that are outperforming are no longer viewing Regulatory Affairs as simply a compliance function. Instead, they’re involving regulatory leaders in strategic decision-making much earlier, investing in specialist expertise, and recognising the direct impact strong regulatory capability has on commercial and development success.

As the market continues to evolve, the organisations that can attract, engage and retain exceptional regulatory talent will be the ones best positioned to deliver their long-term objectives.

Hayley Shayestehroo

Senior Consultant