Quality Assurance and Regulatory Affairs Manager
Vor 7 Tagen
Company Overview:
Scipro is a leading company in the fight against skin cancer, with innovative products launched in Europe, Australia, South Africa, and soon to be available in the US. To support their expansion, they are seeking a talented Quality Assurance and Regulatory Affairs Manager.
Job Description:
The successful candidate will maintain and oversee compliance with quality systems, assist with regulatory submissions, liaise with authorities, train staff on regulatory requirements, prepare for and manage audits and inspections, and manage technical documentation for product submissions. They will also optimize global QA/RA processes and ensure compliance.
Required Skills and Qualifications:
- Degree in engineering or biomedical sciences (Master's/MBA is a plus)
- 3-5 years' experience in quality management and regulatory affairs for medical devices
- Experience with FDA regulatory submissions (510k), quality management systems (ISO 13485/21 CFR 820), and risk management (ISO14971)
- Experience with electrical standards (i.e. IEC60601) or usability would be a plus
- Fluent English required
Estimated Salary: $90,000 - $120,000 per annum
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