Medical Device Safety Specialist

vor 1 Monat


Innsbruck, Tirol, Österreich MED-EL Vollzeit
Job Description

We are seeking a skilled Medical Device Safety Specialist to join our team at MED-EL. In this role, you will be responsible for performing post-market surveillance and vigilance activities in accordance with applicable statutory requirements and internal procedures.

Key Responsibilities:
  • Surveillance Activities: Coordinate recalls and field actions as well as establish and maintain quality system related workflows, processes, and procedures.
  • Data Analysis: Monitor performance and safety of marketed MED-EL medical devices, including quality data trending and product reliability analysis.
  • Incident Investigation: Investigate, evaluate, and follow up on incidents involving MED-EL products.
  • Post-Market Data Compilation: Compile and analyze post-market data for product submissions, clinical evaluation, and annual reports.
Requirements

To be successful in this role, you will need a degree in a technical/medical field or equivalent education, with working experience in the field of vigilance and post-market surveillance desired (minimum two years). You must also have excellent command of written and spoken English, German is desired but not required.

Personality Requirements:
  • Responsible: You will be accountable for ensuring that all post-market surveillance activities are conducted in accordance with regulatory requirements.
  • Independent: You will work independently to investigate incidents, analyze data, and make recommendations for improvements.
  • Analytical: You will use your analytical skills to identify trends and areas for improvement in our medical devices.
  • Solution-Oriented: You will develop and implement solutions to address any issues identified during post-market surveillance activities.
Benefits

We offer a competitive salary and benefits package, including flexible hours, international environment, and opportunities for professional growth and development.

Salary:

The estimated annual salary for this position is €45,000 - €60,000, depending on your level of experience.



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