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Regulatory Affairs Associate

Last update 2024-02-23
Expires 2024-03-23
ID #2028794436
Free
Regulatory Affairs Associate
New Zealand, Southland, Southland,
Modified February 13, 2024

Description

JOB DESCRIPTION Regulatory Affairs Associate Christchurch, New Zealand.· Established Global Healthcare Provider· Contract Role – through to April 2025· Based in Christchurch The Position: This position is responsible to monitor and evaluate the safety, efficacy, and performance of Zimmer Biomet's products.

This role assists in preparing the MDR submission for Ossis products.

In addition, this role is responsible for RA team activities coordination and managing country registrations.

Skills and Experience: Analytical and data driven, the RA Associate will be able to tell a story derived from expert analysis.

You will have strong regulatory understanding of the ANZ environment and be able to work to tight deadlines.

The successful applicant will:· Liaise and coordinate various EU MDR remediation activities and completed MDR technical documentation submissions.· Liaise and coordinate Written of the Technical Documentation File and GSPRs for various Class III and Class IIb products.· Interacting with SMEs to write the different sections of technical documentation, GSPRs and instructions for use.· Engage with SME and support with assess risk documents and FMEAs to verify applicable warnings, precautions, and adverse effects.· Prepare and coordinate responses to various technical, completeness check and clinical rounds of questions from the notified body within defined timelines About Us As the leading innovator in musculoskeletal healthcare, our cutting-edge robotics technology, interactive digital platforms, and comprehensive portfolio of products for joint reconstruction, bone and skeletal repair, sports and spinal injuries, help restore mobility, alleviate pain, and improve the quality of life for patients.

Collaborating with top healthcare professionals around the globe to speed up the pace of innovation, and expand the possibilities for successful treatment outcomes, Zimmer Biomet remains committed to our promise to look beyond what's possible now and discover what's possible next.

Applicants MUST be eligible to live and work in New Zealand.

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Regulatory affairs associate

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