Specialist Regulatory Compliance EMEA (m/w/d)

at  Abbott Laboratories

Abbott Medical is looking for a

EDUCATION & COMPETENCIES

• Knowledge and experience in medical device legislation (MDD, MDR, national legislation)
• Knowledge and experience in post market surveillance
• Experience in cooperation with Competent Authorities
• Technical, natural science, medical background or adequate experience
• Able to cooperate with local teams as well as with the US based manufacturer
• Familiar with Microsoft Office and willingness to work with other databases
• Willingness to meet documentation and follow-up obligations in all areas.
• Fluent in English

PURPOSE OF THE JOB

The Specialist Regulatory Compliance supports EMEA across the cardiovascular und neuromodulation divisions to comply with regulatory requirements of the MDD, MDR, national legislation in EU and non-EU countries, Switzerland, United Kingdom, Middle East and Africa.

ROLES & RESPONSIBILITIES

• Support EMEA countries in understanding and knowledge of the medical device legislation (MDD, MDR, national legislation in EU and non-EU countries, Switzerland, United Kingdom, Middle East and Africa)
• Support countries in the relationship to Competent Authorities, e.g. support Competent Authorities requests for Vigilance Reports or Field Actions.
• Support countries in Post-Market Surveillance activities, e.g. Product Experience Reporting, Field action coordination and execution.
• Support Stop Shipments in EMEA countries.
• Create Training Material and conduct training as appropriate
• Create and generate reports, as required for FSCAs and monthly regulatory reports to monitor regulatory compliance.
• Support Quality Audits in the countries.
• Support EU and CH Authorized Representative and the Person Responsible for Regulatory Compliance.
• Support Verification activities as required for Economic Operators according to the MDR and the CH MedDo.
• Support MDR and CH MedDo projects, e.g. Eudamed, Swissmedic Data Base
• Support Tender upon request from Regulatory Affairs EMEA