Regulatory Compliance Technician

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.

What You Can Expect

This position’s primary focus is to maintain and coordinate the quality management system to ensure compliance with internal and external requirements (corresponding regulations and standards) by supporting the change management, document and record management, training, audit and management review processes. Internal customer focus is essential to successfully collaborate with all Zimmer Biomet departments.

How You'll Create Impact

• Maintain the Quality Management System
• Review and approve processes and their training scope
• Review and approve change requests
• Maintain procedures and work instructions
• Support the development of electronic workflows and their testing
• Coach process owners in process improvement and process creation
• Monitor training effectiveness and completion rate
• Coordination of training needs
• Archiving of documents (Drawings, Change projects, Design Transfer, etc.)
• Assisting in CAPA

Your Background

Education:

• Degree in business or engineering or professional experience in a similar position

Professional experience:

• Experience in procedure writing
• Knowledge of business processes in a regulated environment

Special expertise:

• Familiar with a variety of office software packages including MS Word, Power Point, Visio, Excel
• Preferably knowledge of applicable ISO Standards in particular ISO13485, ISO 9001, ISO14971, the European Medical Device Regulation (MDR) 2017/745, other relevant European directives and general knowledge of US Quality System Regulations (21 CFR 820) and MDSAP

Languages:

• Good command (equivalent to CEFR level B2) in English and German both verbal and written

What Makes You Stand Out

Personal skills requirements:

• Ability to work and think independently
• Managing projects and processes
• Cross boundary teamwork
• Strong customer focus
• Good interpersonal skills
• Good problem-solving ability and analytical skills, strong sense of initiative, follow-through and attention to detail
• Must be able to work with all levels of employees, including hourly production employees through senior management

Travel Expectations

• Less than 5%

EOE/M/F/Vet/Disability