
Regulatory Affairs
1 week ago
**Key Responsibilities**:
- Lead and execute **regulatory submissions** and **technical file preparations** as per **EU MDR, Indian MDR**, and **SFDA** requirements.
- Conduct **Gap Analysis** for GSPR, clinical evaluation reports, IFUs, and labeling compliance.
- Prepare, review, and remediate **Design History Files (DHF)** and Design Control documentation (input, output, verification, validation).
- Participate in and support **ISO 13485 audits**, product audits, and QMS development.
- Manage **Post-Market Surveillance (PMS)** activities and support vigilance reporting per MEDDEV 2.12-1.
- Coordinate with cross-functional teams to manage **design changes**, risk assessments (ISO 14971), and regulatory impact analysis.
- Handle **Notified Body (NB) queries**, regulatory strategy updates, and stakeholder training.
- Guide product teams in compliance with **IEC 60601-1**, **IEC 62366**, **IEC 62304**, and **other relevant device standards**.
- Lead **CAPA/DPA** activities and ensure continuous quality improvement across product lines.
- Stay updated on global regulatory requirements and transfer knowledge across teams.
**Key Skills & Qualifications**:
- Bachelor’s degree in **Biomedical Engineering** or related technical discipline.
- Certifications in **EU MDR, ISO 13485:2016 Lead Auditor, Six Sigma Green Belt**, and **Design Controls**.
- Strong knowledge of **CE Marking**, **Indian CDSCO pathway**, and **FDA & SFDA regulatory pathways**.
- Proficient in **technical documentation**, **internal audits**, **risk management**, and **regulatory compliance**.
- Experience working with **respiratory devices**, **dialyzers**, **IVF equipment**, **patient monitoring accessories**, and more.
- Excellent communication, analytical thinking, and problem-solving skills.
**Tools/Software Experience**:
- Microsoft Office (Word, Excel, PowerPoint)
- Basic experience with **PLM** and **SAP** systems
**Preferred Experience**:
- Experience working with international teams or projects (e.g., Europe, America’s etc)
- Successfully obtained CE certifications and managed global product registrations.
- Experience leading cross-functional audits and team training sessions.
**Job Types**: Full-time, Permanent
Pay: ₹40,000.00 - ₹50,000.00 per month
**Benefits**:
- Food provided
- Provident Fund
Schedule:
- Day shift
Work Location: In person
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