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Zimmer Biomet RA Specialist in Remote, South Korea

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.

Job Summary

Responsible for supporting the regulatory, quality, and post-market surveillance activities.

Principal Duties and Responsibilities

New product registration & Maintenance of existing product licenses

  • Product registration

  • License maintenance – ECN, Renewal

  • Communication and alignment with the global regulatory team to receive support for local product registration and management of local regulatory systems and processes

  • Updating documentation for registration information (e.g., registration master file, SharePoint master file, distribution registration folder)

  • Providing product registration status and results to the business team and related parties to aid in their planning and preparation; working collaboratively with the business team to identify and resolve registration and quality issues for operational effectiveness.

Compliance with MFDS & Corporate QA requirements

  • KGMP audit, including on-site audits and document audits

  • Preparation of Korean labeling documents: Korean IFU & Korean label

Post-market surveillance activities

  • Assess the reportability of global complaints and report foreign adverse events to MFDS

Expected Areas of Competence (i.e. KSAs)

  • Competent English language skills (reading, writing, listening, and fluent speaking)

  • Comprehensive knowledge of MFDS regulations

  • Strong writing and communication skills; ability to communicate effectively at multiple levels including with regulatory authorities

  • Knowledge of medical device products (Implants and/or electronic devices) and regulations and ability to interpret them

  • Ability to manage multiple projects

  • Responsible, professional, detail-oriented

  • Strong computer skills

Education/Experience Requirements

  • Bachelor’s Degree in life sciences, technical (engineering), or related field; advanced degree strongly preferred

  • Minimum of 2-3 years of experience required in Regulatory Affairs and/or Quality

  • Certifications an advantage including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC

Travel Requirements

  • No reason for disqualification for oversea travels