Samd/simd Regulatory Affairs Executive

2 weeks ago

Pimpri Pune Maharashtra, India OPERON STRATEGIST Full time

**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

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