Senior Vigilance Specialist

The Senior Vigilance Specialist is responsible for developing vigilance activities such as Adverse Event Reporting and Field Action coordination and execution. The position will support the development governance and integration of Vigilance processes and ensure effective execution into our QMS.

This position is part of the On-Market Sustainment Team and will be located in Sweden Solna. At Cepheid our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role you will have the opportunity to:

• Ensure Field Actions execution and Adverse Event reporting are performed in compliance with applicable regulations

• Ensure complete and accurate maintenance and reporting of Adverse Event Reports as required by regulatory agencies

• Understand current and upcoming Adverse Event reporting requirements by regulatory bodies and ensure adequate implementation

• Lead Field actions execution (Field action reporting to Authorities disseminating communications).

• Act as Subject Matter Expert (SME) for Regulatory Authorities facility inspections Notified Body Audits and other governmental inspections as directed.

The essential requirements of the job include:

• Bachelors degree in field with 5 years of related work experience OR Masters degree in field with 3 years of related work experience OR Doctoral degree in field with 0-2 years of related work experience.

• Strong understanding of quality systems methodology and applications.

• Knowledge of domestic and international quality systems and other standards such as IVDR FDA QMSR MDD CMDCAS SFDA JPAL ISO 13485 ISO 14971 and other applicable standards and regulations.

Please note that because of summer vacations there may be a delay in reviewing applications and providing updates on your candidacy. We appreciate your patience and look forward to being in touch.

Cepheid a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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