Head of Quality & Regulatory Affairs, Endovascular Robotics
Tasks
- Act as PRRC for regulatory compliance
- Develop quality and regulatory affairs teams
- Develop quality assurance programs policies and processes
- Drive global regulatory strategy for new submissions
- Lead quality compliance with applicable regulations
- Manage clinical stage regulatory activities
- Manage regulatory pathways across key markets
- Monitor regulatory developments and enforcement trends
- Oversee audit programs supplier quality CAPA and inspection readiness
- Oversee regulatory affairs strategy
- Prepare and approve regulatory submissions and technical documentation
- Provide regulatory guidance for clinical study design and approvals
- Serve as liaison with regulatory bodies
Perks/Benefits
- 401k retirement plan
- Dental insurance
- Life insurance
- Long-term disability insurance
- Medical insurance
- Paid parking
- Paid sick time
- Paid time off
- Short-term Disability Insurance
- Vision insurance
Skills/Tech-stack
Audit management | CAPA | CE marking | CE marking MDR | CFR 21 | Clinical trials | EU MDR | Electromechanical Systems | Ethics Committee | FDA | FDA Submissions | GMP | IRB | ISO 13485 | Management System | Medical Device | Medical device clinical trials | Medical device regulation | Medical software | NMPA | QMSR | QSR | Quality Assurance | Quality Management System | Quality management | Regulatory Compliance | Regulatory strategy | Robotics | SaMD
Education
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