Regulatory Affairs Systems Associate
Zimmer Biomet
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.
**What You Can Expect**
As part of our Regulatory Affairs (RA) team for the EMEA Region, the RA Systems Associate will play a crucial role in ensuring the compliance and success of our product registration submissions.
**How You'll Create Impact**
+ Prepare and submit regulatory dossiers for product registrations, renewals, and variations in the EMEA region using specialized regulatory software systems.
+ Ensure accurate data entry and efficient use of regulatory software tools and maintenance of product information in the Windchill System.
+ Collaborate with cross-functional teams to gather required documentation and technical information for submissions.
+ Monitor and track the requirements and updates in the EMEA region to ensure submission and documentation accuracy.
+ Stay updated on regulatory requirements, guidelines, and changes across the EMEA region.
+ Maintain up-to-date records of regulatory submissions, approvals and correspondence in internal regulatory systems.
+ Assist in creating and updating Standard Operating Procedures (SOPs) related to regulatory submissions.
+ Participate in internal and external audits to ensure compliance with regulatory standards.
+ Support process improvement initiatives to enhance efficiency and accuracy of submissions.
+ Stay informed about changes in regulatory frameworks and software tools within the EMEA region to ensure ongoing compliance and efficiency.
**What Makes You Stand Out**
+ Familiarity with regulatory submission processes and requirements in the EMEA region.
+ Proficiency in using regulatory systems, preferably Windchill or similar tools.
+ Strong attention to detail and ability to manage multiple tasks effectively.
+ Excellent communication and interpersonal skills to collaborate with diverse teams.
+ Ability to work independently and demonstrate problem-solving skills.
+ Proficiency in English; Polish is a plus; additional languages are a plus.
**Your Background**
+ Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field.
+ 0-3 years of experience in regulatory affairs, preferably within the medical device or pharmaceutical industry.
EOE/M/F/Vet/Disability
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