Skills Alliance
Consultant | Medical Devices | QARA United States & Europe
Regulatory Manager – Point-of-Care Diagnostics
I’m partnered with a fast-growing medical diagnostics startup developing
point-of-care technology
that provides rapid insight into a patient’s coagulation status. Their platform is already progressing in the EU and gaining strong clinical traction.
They’re now looking for a
hands‑on Regulatory Manager
to drive EU regulatory strategy and submissions as they scale.
The Role
Lead and support regulatory activities with strong focus on
EU CE/IVDR submissions .
Prepare, coordinate, and maintain technical documentation for CE/IVDR.
Integrate regulatory requirements across the product lifecycle (hardware, consumables & software).
Act as point of contact with Notified Bodies; support audits, Q&A, and remediation.
Partner with Quality, Engineering, and R&D on documentation, risk management, and compliance.
The Profile
5–8+ years’ Regulatory Affairs experience
in medical devices or diagnostics.
Proven experience working on
CE/IVDR submissions .
Strong familiarity with
ISO 13485, ISO 14971, IEC 62304, and EU regulatory frameworks .
Comfortable in a
startup environment,
hands‑on, adaptable, and collaborative.
Why This Role
Shape regulatory strategy in a scaling, high‑impact environment.
Work on technology with meaningful clinical application in emergency and critical care.
Highly cross‑functional role with broad ownership and visibility.
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I’m partnered with a fast-growing medical diagnostics startup developing
point-of-care technology
that provides rapid insight into a patient’s coagulation status. Their platform is already progressing in the EU and gaining strong clinical traction.
They’re now looking for a
hands‑on Regulatory Manager
to drive EU regulatory strategy and submissions as they scale.
The Role
Lead and support regulatory activities with strong focus on
EU CE/IVDR submissions .
Prepare, coordinate, and maintain technical documentation for CE/IVDR.
Integrate regulatory requirements across the product lifecycle (hardware, consumables & software).
Act as point of contact with Notified Bodies; support audits, Q&A, and remediation.
Partner with Quality, Engineering, and R&D on documentation, risk management, and compliance.
The Profile
5–8+ years’ Regulatory Affairs experience
in medical devices or diagnostics.
Proven experience working on
CE/IVDR submissions .
Strong familiarity with
ISO 13485, ISO 14971, IEC 62304, and EU regulatory frameworks .
Comfortable in a
startup environment,
hands‑on, adaptable, and collaborative.
Why This Role
Shape regulatory strategy in a scaling, high‑impact environment.
Work on technology with meaningful clinical application in emergency and critical care.
Highly cross‑functional role with broad ownership and visibility.
#J-18808-Ljbffr