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  •    Bringing a medical product to market?                                                                 
  •    Need coverage for your full range of
           quality system initiatives?                                                                 
  •    Need a firm to address, develop and
          manage a regulatory strategy?                                                                 
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Quality / Validation / Regulatory Recruiting

Boston: Randolph, MA


The Medical Device industry is in a constant state of evolution. Keeping up with technology as well as regulatory changes requires a dedicated effort. Medical device companies require experienced, talented staff to achieve their goals.

Our Quality, Validation and Regulatory recruiting practice provides talent acquistion and consulting services focused on the Medical Device industry. We provide highly skilled, prescreened professionals educated in all the latest medical device regulations with specific focus on Regulatory, Validation and Quality.

We work to improve your hiring efficiencies by providing a fully vetted, select group of qualified candidates that we have either developed a long standing relationship with, or have engaged on multiple projects. Our Quality, Validation and Regulatory recruiting methodology effectively improves the “time-to-fill” for critical positions, allowing our clients to meet deadlines, plan new projects and drive business forward.


We are ready to demonstrate to you The Whitridge Way.





  • Provide Remediation, Consent Decree, Warning Letter and Recall support
  • Root cause investigation, Complaint, CAPA and Deviation Management
  • Gap Assessment, Risk Management and Change Control
  • Develop Methodologies, policies, Quality Systems, Training and Documentation
  • Writing and executing Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
  • Facilities/Utilities validation, Equipment validation, Process validation, Test Method Validation, Computer Systems Validation, Automated Equipment Validation, Software Validation, and Validation Master Plans (VMPs)
  • Process Improvement, Risk Management, Lean Six Sigma, Controls Engineering, Manufacturing Engineering, writing Standard Operating Procedures (SOPs)
  • Regulatory strategy, writing submissions, technical documentation, remediation and Investigational Device Exemptions
  • 510K Submissions, Premarket Approvals (PMA’s), Investigational New Drug (IND) Applications, Chemistry, Manufacturing & Controls (CMC) submissions and New Drug Applications (NDA)


About Whitridge Associates:

  • Our Quality, Validation, and Regulatory recruiting team services Medical Device clients
  • We provide talent to meet our medical device client’s needs
  • Our Quality, Validation, and Regulatory consultants are highly skilled professionals educated in all of the latest medical device regulations
  • Proven expertise in qualifying candidates for specialized opportunities
  • We specialize in filling not only highly skilled individual contributor roles, but also management level positions that match your company culture

Think Whitridge. Think Success.