SaMD, Regulatory, MULTIPLE ROLES
3 days ago
QualBizz is looking for Immediate joiners for its client. Email to
5+ years
of experience with
multiple positions.
SME
level 15 + experience,
one position
Hybrid, Bangalore Location
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
- 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
- 5– 15 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 - 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.
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