Regulatory Affairs Specialist (Contract)

Job description

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 recognised.

Job Summary

• This is a maternity leave replacement contract position with an expected contract duration from October 2026 to March 2028. New product registration & Maintenance of existing product licenses Compliance with MFDS & Corporate QA requirements

Principal Duties & Responsibilities

1. New product registration & Maintenance of existing product licenses (90%) New product registration, Line-extension registration Amendment of licenses, License renewal Communicate and align with the global regulatory team to get support for local product registration and manage local regulatory systems and processes. Documentation update for registration information (Update for; Registration master file, Sharepoint master file, Distribution registration folder, etc.) Provide product registration status and results to the business team and related parties to help their plan and preparation in advance, work collaboratively with the business team, and identify and seek resolution of registration and quality issues for the operational effectiveness 2.

Compliance with MFDS & Corporate QA requirements (10%) KGMP maintenance e.g. on-site audit and document audit Preparation of Korean labeling documents; Korean IFU & Korean label Prepare/revise/control QM, PD, and SOP to ensure compliance with the Corporate and the MFDS requirements for Korean operation Track and follow up on the new regulation/requirement (e.g. GMP, GSP, MDA, etc.)

• Individual percentages should be greater than or equal to 5%. This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Requirements

• Expected Areas of Competence 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
• 37 years of experience required in Regulatory Affairs and/or Quality Certifications an advantage including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC Travel Expectations No reason for disqualification for overseas travels EOE/M/F/Vet/Disability