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Citiustech
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Regulatory Affairs - Medical Devices

Regulatory Affairs - Medical Devices

Citiustech

4 - 9 years

10 - 20 Lacs

hyderabad pune chennai

Posted:2 days ago| Platform:

Apply

Skills Required

regulatory affairs medical devices regulatory compliance samd software development fda mdr medical regulatory

Work Mode

Hybrid

Job Type

Full Time

Job Description

Key Responsibilities

Provide regulatory strategy and compliance guidance for
SaMD
and
software-intensive medical devices
.
Interpret and apply global regulations (FDA, EU MDR, UKCA, Health Canada, etc.) and standards (ISO 13485, IEC 62304, ISO 14971, IEC 82304-1).
Prepare and review regulatory submissions (510(k), CE Technical Files, UKCA documentation).
Support
risk management
,
cybersecurity compliance
, and
software lifecycle documentation
.
Collaborate with engineering teams to align design controls, verification/validation, and usability engineering with regulatory requirements.
Stay updated on evolving regulations for
AI/ML-based SaMD
and digital health solutions.

Required Skills & Experience

4 to 8 years
in regulatory affairs for medical devices, with strong exposure to
software and SaMD
.
Hands-on experience with
IEC 62304
,
ISO 14971
, and
cybersecurity standards
(e.g., FDA premarket guidance, IEC 81001-5-1).
Proven track record in preparing regulatory submissions for software-based devices.
Familiarity with
AI/ML regulatory frameworks
and
real-world evidence
considerations is a plus.
Strong communication skills to interface with global clients and cross-functional teams.

Must Have skill:

Experience:

Location:

Notice:

How to Apply:

manojkumar.sampathkumar@citiustech.com

Total experience:
Relevant experience in Regulatory Affairs:
Relevant experience in SDLC / SaMD:
Relevant experience in Medical Device:
Current CTC:
Expected CTC:
Notice period:
Current Location:
Preferred location:

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