.Welcome to ZimVie, a new, publicly traded global company focused on improving quality of life for our patients.
Our company is founded on a legacy of established brands, medical experts and over $1B in annual revenue.
We design, manufacture, and distribute a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery and bone growth stimulation.
Our seasoned leadership and dedicated global team of more than 2,500 is focused on shaping an exciting future for ZimVie — we hope you'll consider being a part of it!
Job Summary The mission of the Regulatory Compliance Engineer is to perform the management of claims, market withdrawals, exchange controls, External Product Hold and Internal Audits according to the corporate procedures, guidelines and standards.
Main Duties and Responsibilities Make notifications of product incidents of the company to the competent Health Authorities and Notified Bodies.
Manage product withdrawals and incidents, making the necessary notifications to the Spanish Agency for Medicines and Health Products (AEMPS).
Make changes and updates to local standards, resulting from the implementation of corporate procedures and other changes.
Review and manage change controls (DCRs/ECRs) and carry out any derived action.
Manage activities related to product holds, recalls and claims.
Provide data for indicator reports of Quality Assurance activities.
Manage and perform Internal Quality Audits.
Education/Experience Requirements 2-3 years' experience in a similar position, especially in a multinational environment.
Higher studies in Health, Sciences or Engineering fields.
Postgraduate studies in Quality systems is an asset.
Fluency in Spanish and English is mandatory, both verbal and written.
Proficiency in computer skills, MS Office (Excel).
Knowledge of regulations ISO 9001, 13485, EU MDR 2017/745.
Excellent planning, detail-oriented, organization and prioritization.
Ability to take decisions, analysis and problem-solving.
Ability to build relationships with other areas of the company.
Additional Information As a ZimVie team member, we want you to feel included, respected, empowered, and celebrated.
We offer competitive salaries and benefits, as well as employee recognition and career enrichment opportunities.
Competitive salary Flexible working arrangements Ticket Restaurant Private life & health insurance Dining and leisure area Well-being activities and other benefits ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace