Senior Regulatory Specialist

Overview

We are seeking a highly skilled Senior Regulatory Specialist to join our team. The ideal candidate will have a strong background in quality assurance and regulatory compliance, with expertise in medical device software lifecycle processes.

Responsibilities

• Maintain the quality system documentation processes and procedures adopted by the company.
• Investigate and resolve quality issues, implementing corrective and preventive actions to mitigate recurrence.
• Coordinate and support the preparation of software technical documents appropriate for regulatory submissions.
• Support the regulatory submissions for market authorization for medical device products.
• Conduct internal assessments and audits to identify areas for improvement and ensure adherence to established procedures.
• Facilitate the approval process for software releases.
• Disseminate knowledge about the Quality System and regulatory requirements.
• Review Promotional and advertising materials.
• Oversee post-market surveillance activities related to medical device products.

Qualifications

Benefits

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