Senior QARA Specialist

JOB SUMMARY

Within a medical device environment, work with the QARA Manager to ensure regulatory compliance and certification of software products.

KEY ACCOUNTABILITIES

• Collaborate in maintaining 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.
• Disseminating knowledge about the Quality System and regulatory requirements.