Associate MDR/Vigilance Specialist

Location
Galway
Salary
Negotiable
Posted
23 Apr 2021
Closes
06 May 2021
Ref
BBBH3296
Contact
Megan Power
Sector
Manufacturing
Job Type
Contract
Hours
Full-time

Title: Assoc MDR/Vigilance Specialist

Duration: 23 months

Location: Work from home / Galway

Start Date: ASAP

Main Duties and Responsibilities:

(Responsibilities may include the following and other duties may be assigned)

* Part of a team responsible for the management of all incoming product events from a range of sources and geographies. * Responsible for the data entry of field complaints reported for medical devices into complaint database, including documentation review and complaint assessment. * Support Vigilance and Medical Device Report (MDR) regulatory reporting by ensuring timely assessment of incoming complaint events. * Support complaint trend analysis and issuance of key reports to relevant departments. * Contribute to continuous improvement activities to support efficiency and productivity gains opportunities within the PXM department. * Build product knowledge and technical expertise of the product group you support. * Adherence to procedures at all times to ensure compliance. * Ensure highest quality of product event data entry for accuracy of reporting to regulatory agencies.

KEY SKILLS & EXPERIENCE

* Bachelor's degree in Science or related discipline

* We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams.

* Experience/understanding of complaint handling or CAPA processes are desirable.

* Candidates must be able to think critically and make sound decisions.

* Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour.

* Candidates must be a good communicator and are fluent in English, both in writing and speaking.

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