Job Information
Zimmer Biomet QA Specialist in Seoul, 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
EOE/M/F/Vet/Disability