Regulatory Affairs Systems Specialist

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**:
Regulatory Affairs (RA) Specialist for systems team provides support for the maintenance and implementation of RA systems, with particular focus on Regulatory Information Management System (RIMS) and Regulatory Distribution Controls through SAP Global Trade Services (GTS) software. This position requires experience with data analysis and data mining.

**How You'll Create Impact**:

- Support Business Unit RA activities including publishing, filing, establishment registrations, product listing with the FDA, etc.
- Create and maintain regulatory affairs registrations and licenses in RIMS/GTS distribution control systems in support of regulatory controls for global product distribution.
- Release and management of RA blocks.
- Generate and communicate GTS/distribution control reports in a timely fashion.
- Maintain records (objective evidence) per established procedures.
- Maintain GTS/distribution control block tracker.
- Perform and support User Acceptance Testing (UAT) as needed for RIMS and GTS.
- Work closely with global RA teams and customer service to resolve issues related to GTS/distribution control blocks and maintenance of objective evidence.
- Conduct appropriate gap analysis on the existing license master data and develop summaries using advanced Excel and other data analysis tools.
- Upload and maintain RA data in RIMS and GTS system using automated upload tools and troubleshoot data errors as needed.
- This position requires a level of understanding of software validation and testing protocols.
- This position requires an understanding of medical devices regulations and their use.
- Understanding of distribution, logistics and order flow from various Enterprise Resource Planning (ERP) Systems used by the company to GTS.
- Conduct training for the team members on tools and techniques for maintaining data integrity.
- Support the creation of training materials and work instructions.
- Support the generation of queries, metrics and reports.
- Maintain compliance with RA Procedures and Work Instructions.
- Ability to work with cross-functional teams.

**What Makes You Stand Out**:

- Preferred experience with global regulatory systems.
- Preferred experience/projects related to data mining tools and advanced Excel skills.
- Strong writing, communication, and interpersonal skills.
- Strong problem-solving and analytical skills.
- Knowledge of EU, EMEA, APAC, LATAM, or US regulations pertinent to medical devices, biologics, drugs and combination products
- Attention to detail and capable of working in an organized and consistent manner.
- Software Skills
- SAP modules, SAP GTS, ERP systems, Microsoft Office Suite, Adobe Professional and Excel for data analytics

**Your Background**:

- English Proficiency is required (B2 or C1)
- Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
- A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required

**Travel Expectations**:
EOE/M/F/Vet/Disability