Recruiting Quality & Regulatory Talent for Medical Device Companies
Specialized expertise. Deep industry networks. Delivering direct hire talent that drives quality, compliance, and market access.
West Leland Group is a boutique recruiting firm specializing in Quality Assurance and Regulatory Affairs hires for Medical Device companies. With over a decade of experience and strong Midwest roots, we help teams build talent that drives product quality, compliance, and market access. Learn more
Recruiting for Medical Device and other Regulated Industries
We partner with companies operating within FDA-regulated industries, with a core focus on Medical Device organizations developing Class I, II, and III technologies. Our experience includes both product and service-based settings, with strong coverage across the Midwest. We also support select searches in Pharmaceutical, Biotechnology, and Regulated Packaging industries nationwide.
Industries
- Medical Device
- Pharmaceutical
- Biotechnology
- Regulated Packaging
We specialize in regulated industries, with a core focus on Medical Device.
Client Types
- Startups
- Original Equipment Manufacturers (OEMs)
- Contract Manufacturers (CDMOs & CMOs)
- Private Equity
We partner with both product and service-based companies at all stages of growth.
Geographies
- Greater Chicago
- Twin Cities
- Indiana
Core focus on established Midwest hubs, with reach across neighboring markets and select national searches.
Roles We Specialize In
We specialize in direct-hire placements across Quality Engineering, Quality Systems, and Regulatory Affairs. From hands-on contributors to senior leadership, we understand the talent required to thrive in regulated environments.
Our work is rooted in Medical Device hiring and backed by deep industry networks and functional expertise. We focus on identifying professionals who bring technical skill, clear communication, and meaningful results.
Quality Engineering
- Quality Engineer
- Validation Engineer
- NPI Quality Engineer
- Design Quality Engineer
- Supplier Quality Engineer
- Risk Management Engineer
- Quality Program Manager
Areas of expertise include Design Controls, risk management (ISO 14971), process validation (IQ/OQ/PQ), statistical analysis (SPC, DOE), and continuous improvement using Six Sigma and Lean.
Quality Systems
- Quality Systems Specialist
- Complaint Specialist
- CAPA Specialist
- Internal Auditor
- Document Control Specialist
- Change Control Specialist
- Quality Systems Engineer
Experience includes audits, CAPA, complaints, document control, and change management. We support compliance with 21 CFR Part 820, ISO 13485, and evolving QMSR expectations.
Regulatory Affairs
- Regulatory Affairs Specialist
- Regulatory Affairs Associate
- Regulatory Affairs Project Manager
- Regulatory Operations Specialist
- Regulatory Labeling Specialist
- EU MDR Program Manager
- UDI Program Manager
Focus areas include 510(k), PMA, CE marking, labeling, UDI, and EU MDR. We support U.S. and international submissions, including SaMD, cybersecurity, and eSTAR.
QA & RA Leadership
- Quality Manager
- Regulatory Affairs Manager
- Director of Quality
- Director of Regulatory Affairs
- Director of QA/RA
- Vice President of Quality
- Vice President of Regulatory Affairs
We support QA and RA leadership roles across all company sizes, including hybrid positions that span both functions.
Our Approach
Engagement Models
Flexible options aligned to your needs.
We offer both contingent and retained search models, allowing teams to engage in a way that fits their urgency, complexity, and internal process. Whether you’re looking for added sourcing support or a dedicated partner from kickoff through hire, we adapt to your team’s priorities and hiring goals.
Integrated Partnership
Built to fit your internal workflows.
We take time to understand how your team evaluates talent — including interview steps, stakeholder input, and approval processes. That context lets us align with your internal workflows, whether we’re working directly with hiring managers, partnering with TA, or supporting HR. The result is a smoother process for your team and a better experience for candidates.
Strategic Search
Powered by relationships, advanced sourcing tools, and functional expertise.
Each search begins with established networks, informed talent maps, and a strong understanding of the roles and environments we recruit for. Our approach combines proven sourcing methods and modern research tools to reach top talent, especially passive candidates. The result is targeted outreach that moves quickly, without sacrificing the personal touch that drives engagement and trust.
Brand Representation
Your reputation matters. We protect it in every interaction.
We act as an extension of your brand in the market. That includes representing your company professionally, telling your story clearly, and treating candidates with respect. Every interaction reflects your reputation, and even those who don’t join your team leave with a positive impression.
What Sets Us Apart
Focused Expertise
We specialize in Quality and Regulatory hiring for Medical Device companies. That focus lets us go deeper, move faster, and deliver talent that fits.
Proven Experience
Every search is led by a recruiter with over a decade of experience recruiting Quality and Regulatory professionals. That brings sharper evaluation, stronger alignment, and a more professional process from start to finish.
Stronger Candidate Engagement
We bring your opportunity to life by understanding your team, your products, and what sets you apart. Candidates come away with a clear and compelling view of your company.
Simple, Streamlined Collaboration
It’s easy to get started and easy to keep moving. Our structure allows for quick setup, clear communication, and a process that respects your time and priorities.
About West Leland
West Leland Group is a boutique direct hire recruiting firm based in Chicago. We specialize in placing Quality Engineering, Regulatory Affairs, and Quality Systems for Medical Device companies.
With over a decade of experience, we partner with organizations ranging from early-stage startups to global manufacturers. We help build teams that support product quality, regulatory compliance, and market access. Our placements span engineering, specialist, and leadership levels, with deep networks across greater Chicago, Minneapolis–St. Paul, and other key Midwest markets.
Every search is led by a senior recruiter and managed with a consultative, hands-on approach. Our process is grounded in technical fluency, functional expertise, and a clear understanding of the demands of regulated environments. We offer both contingent and retained search models to align with your team’s timeline, complexity, and hiring priorities. Our goal is to strengthen teams, elevate brand reputation, and drive lasting impact through every hire.
West Leland was founded to provide companies with a recruiting partner who understands the nuances of regulated industries and how to identify the talent required to bring safe, effective technologies to patients.
While our core focus is the Medical Device industry, we also support select searches in Pharmaceutical and Biotech sectors.
