Regulatory Affairs Manager
21 hours ago
Arevna is seeking a Regulatory Affairs Manager to oversee our regulatory compliance efforts for medical device products. The ideal candidate will have strong knowledge of ISO 13485, FDA 21 CFR Part 820, and MDR requirements, as well as experience with CAPA, non-conformance investigations, and root cause analysis.
The estimated salary for this position is around $100,000 per year, depending on the location and experience.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with medical device regulations.
- Conduct audits and assessments to identify areas for improvement.
- Collaborate with cross-functional teams to address non-conformities, deviations, CAPAs, and complaints.
Required Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- Minimum of 5 years of experience in quality assurance or quality control within a medical device environment.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and MDR requirements.
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