![Zimmer Biomet](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs Systems Specialist
4 tygodni temu
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 a Regulatory Affairs Specialist for systems team, you provide 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 Create Impact
Create and maintain regulatory affairs registrations and licenses in RIMS/GTS distribution control systems in support of regulatory controls for global product distribution. Generate and communicate distribution control reports in a timely fashion. Maintain records (objective evidence) per established procedures. 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. Apply technical expertise in data mining and modeling tools to provide insights into distribution control data for RA and suggest appropriate measures for enhancement of existing processes. 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.
What Will Make You Stand Out
You hold a bachelor’s degree in science or engineering, an advanced degree is a plus.
In addition you have at least 3 to 5 years of experience in data analysis and data mining, ideally in a multicultural environment related to Regulatory Affairs, Engineering or Quality. An experience with global regulatory systems is preferred.
You have developed strong skills such as:
Understanding of software validation and testing protocols. Understanding of distribution, logistics and order flow from various Enterprise Resource Planning (ERP) Systems used by the company to GTS. Software Skills- SAP modules, SAP GTS, ERP systems, Microsoft Office Suite, Adobe Professional and Excel for data analytics Knowledge of EU, EMEA, or US regulations pertinent to medical devices, biologics, drugs and combination products English Proficiency is required; knowledge of additional EU languages is preferred.
What Will Make You Successful
Strong writing, communication, and interpersonal skills. Strong problem-solving and analytical skills. Attention to detail and capable of working in an organized and consistent manner. Ability to work with cross-functional teams.
Who We Are
Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
Looking to make an impact? Join us and make a difference.
Learn more about us by visiting zimmerbiomet.com
EOE/M/F/Vet/Disability
-
Regulatory Affairs Systems Specialist
4 tygodni temu
Warsaw, Polska Zimmer Biomet Pełny etatValued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!What You Can ExpectAs a Regulatory Affairs Specialist for systems team, you provide support for the maintenance and implementation of RA systems, with particular focus on Regulatory Information Management System (RIMS) and Regulatory Distribution Controls through SAP...
-
Regulatory Affairs Systems Specialist
4 tygodni temu
Warsaw, Polska Zimmer Biomet Pełny etatValued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!What You Can ExpectAs a Regulatory Affairs Specialist for systems team, you provide support for the maintenance and implementation of RA systems, with particular focus on Regulatory Information Management System (RIMS) and Regulatory Distribution Controls through SAP...
-
Regulatory Affairs Specialist
4 tygodni temu
Warsaw, Polska Smith+Nephew Pełny etatLife Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Regulatory Affairs Specialist is responsible for representing and supporting the regulatory activities in NON EU-CEE Export Markets. What will you be doing: Provide accurate, timely and balanced Regulatory Affairs support to the business...
-
Regulatory Affairs Specialist
1 miesiąc temu
Warsaw, Polska Smith+Nephew Pełny etatLife Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Regulatory Affairs Specialist is responsible for representing and supporting the regulatory activities in NON EU-CEE Export Markets. What will you be doing: Provide accurate, timely and balanced Regulatory Affairs support to the business...
-
Senior Regulatory Affairs and Quality Assurance Specialist
1 miesiąc temu
Warsaw, Polska Stryker Pełny etatAre you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the...
-
Senior Regulatory Affairs and Quality Assurance Specialist
4 tygodni temu
Warsaw, Polska Stryker Pełny etatAre you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the...
-
Regulatory Affairs Manager
3 tygodni temu
Warsaw, Polska Innovaderm Research Pełny etatThe Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm’s standard operating procedures, applicable regulations and good clinical practices and to the Sponsor’s satisfaction. Responsibilities include providing leadership on regulatory activities...
-
Regulatory Affairs
2 miesięcy temu
Warsaw, Polska People Sp. z o.o. Pełny etatDla Naszego Klienta – międzynarodowej firmy z branży farmaceutycznej poszukujemy osoby na stanowisko:Regulatory Affairs / Pharmacovigilance SpecialistLokalizacja: Warszawa Śródmieście (praca hybrydowa)Zakres obowiązków:Działania związane z utrzymaniem pozwoleń na dopuszczenie do obrotu (MA), odpowiedziami na pytania i zobowiązania regulacyjne,...
-
Regulatory Affairs
4 tygodni temu
Warsaw, Polska People Sp. z o.o. Pełny etatDla Naszego Klienta – międzynarodowej firmy z branży farmaceutycznej poszukujemy osoby na stanowisko:Regulatory Affairs / Pharmacovigilance SpecialistLokalizacja: Warszawa Śródmieście (praca hybrydowa)Zakres obowiązków:Działania związane z utrzymaniem pozwoleń na dopuszczenie do obrotu (MA), odpowiedziami na pytania i zobowiązania regulacyjne,...
-
Regulatory Affairs Manager CEE
1 miesiąc temu
Warsaw, Polska Galderma Pełny etatGalderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our...
-
Regulatory Affairs Manager CEE
4 tygodni temu
Warsaw, Polska Galderma Pełny etatGalderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our...
-
Intern, Regulatory Affairs
3 tygodni temu
Warsaw, Polska SC Johnson Professional Pełny etatIntern, Regulatory Affairs Assistant to Regulatory and Registration Manager Location: Warsaw Overview The purpose of an internship is to provide real-world experience that enables the intern to put everything he/she learned into action. An internship can help the candidate gain skills that can be applied to future jobs. As an Intern,...
-
Intern, Regulatory Affairs
3 tygodni temu
Warsaw, Polska SC Johnson Pełny etatIntern, Regulatory Affairs Assistant to Regulatory and Registration Manager Location: Warsaw Overview The purpose of an internship is to provide real-world experience that enables the intern to put everything he/she learned into action. An internship can help the candidate gain skills that can be applied to future jobs. As an Intern,...
-
Senior Manager Regulatory Operations
2 miesięcy temu
Warsaw, Polska Perrigo Pełny etatDescription Overview Within the Consumer Self-Care International business unit (main focus on Europe), lead the growing and evolving Regulatory Affairs Operations team responsible for centralised Regulatory systems & processes and Regulatory data management & compliance. Scope of the Role The main objectives of the job are To be the main...
-
Senior Manager Regulatory Operations
4 tygodni temu
Warsaw, Polska Perrigo Pełny etatDescription Overview Within the Consumer Self-Care International business unit (main focus on Europe), lead the growing and evolving Regulatory Affairs Operations team responsible for centralised Regulatory systems & processes and Regulatory data management & compliance. Scope of the Role The main objectives of the job are To be the main...
-
Regulatory Submission Specialist
2 miesięcy temu
Warsaw, Polska Publicis Le Pont Pełny etatJob Description As a Regulatory Submission Specialist, you will be responsible for researching medical documents, finding the correct references for pharmaceutical marketing assets, submitting this content into Veeva Vault platform and maintaining internal processes and project management. The role will be perfect for you if you have strong...
-
Regulatory Submission Specialist
4 tygodni temu
Warsaw, Polska Publicis Le Pont Pełny etatJob Description As a Regulatory Submission Specialist, you will be responsible for researching medical documents, finding the correct references for pharmaceutical marketing assets, submitting this content into Veeva Vault platform and maintaining internal processes and project management. The role will be perfect for you if you have strong...
-
Regulatory Operations Senior Manager
1 miesiąc temu
Warsaw, Polska Michael Page Pełny etatTo be the main contact/representative for Regulatory Affairs (RA) in business initiatives/projects involving or impacting data, systems and processes (Enterprise Content Management, Product Lifecycle Maintenance, Change Control)To drive business initiatives/projects involving or impacting RA data, systems and processes (Regulatory Information Management...
-
Regulatory Operations Senior Manager
4 tygodni temu
Warsaw, Polska Michael Page Pełny etatTo be the main contact/representative for Regulatory Affairs (RA) in business initiatives/projects involving or impacting data, systems and processes (Enterprise Content Management, Product Lifecycle Maintenance, Change Control)To drive business initiatives/projects involving or impacting RA data, systems and processes (Regulatory Information Management...
-
Regulatory Affairs Lead, CEE Export Markets
2 tygodni temu
Warsaw, Polska Haleon Pełny etatHello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of...