Job Description

Key Responsibilities:

Prepare, compile, and submit regulatory documentation for SaMD/SIMD products, including 510(k), CE marking (under MDR), UKCA, and other global regulatory submissions. Ensure SaMD product development and maintenance align with relevant standards such as

IEC 62304

,

ISO 14971

,

ISO 13485

,

ISO 27001

, and applicable cybersecurity guidance. Maintain up-to-date knowledge of regulatory requirements and guidance related to SaMD (e.g., FDA's premarket guidance, EU MDR Annex VIII, IMDRF SaMD framework). Provide regulatory input into product design and development documentation, including risk management, clinical evaluation, and labeling. Manage regulatory interactions with notified bodies and competent authorities. Support post-market surveillance, adverse event reporting, and regulatory compliance activities. Participate in audits and inspections. Monitor changes in global regulations and communicate impact to internal stakeholders.

Qualifications:Education:

Bachelor's Biomedical Engineering, Information Technology, Computer Engineering or a related field.

Experience:

1-4 years of experience in regulatory affairs, preferably with a focus on

SaMD or Digital Health

. Hands-on experience with regulatory submissions in key markets (FDA, EU, UK). Familiarity with software development lifecycle and documentation for regulated medical software. Experience working in a regulated environment (ISO 13485, QMS).

Skills:

Strong knowledge of global SaMD regulatory frameworks. Excellent written and verbal communication skills. Ability to interpret technical documentation and translate regulatory requirements clearly. Strong organizational and project management abilities.

Preferred:

Experience with Agile software development. Knowledge of AI/ML in SaMD and associated regulatory considerations.
Job Types: Full-time, Permanent

Pay: ?350,000.00 - ?450,000.00 per year

Benefits:

Cell phone reimbursement Health insurance Leave encashment Provident Fund
Schedule:

Day shift Monday to Friday Weekend availability
Work Location: In person

Expected Start Date: 01/08/2025