Regulatory Compliance Systems Specialist
hace 2 semanas
At Zimmer Biomet, we are dedicated to advancing innovation and fulfilling our mission. As a prominent leader in medical technology for nearly a century, our products and technologies enhance patient mobility every 8 seconds.
As a member of the Zimmer Biomet team, you will contribute to our commitment to restoring mobility and improving lives globally. We prioritize development opportunities, inclusive employee resource groups (ERGs), a flexible work environment, competitive rewards tailored to specific locations, wellness incentives, and a culture that values recognition and performance.
Role Overview
The Regulatory Affairs (RA) Systems Specialist within our systems team plays a crucial role in supporting the upkeep and implementation of RA systems, particularly focusing on the Regulatory Information Management System (RIMS) and Regulatory Distribution Controls via SAP Global Trade Services (GTS) software. This role demands expertise in data analysis and mining.
Key Responsibilities
- Assist Business Unit RA functions including documentation, submissions, establishment registrations, and product listings with regulatory authorities.
- Develop and manage regulatory registrations and licenses within RIMS/GTS distribution control systems to ensure compliance for global product distribution.
- Oversee the release and management of RA blocks.
- Produce and disseminate GTS/distribution control reports promptly.
- Maintain records (objective evidence) according to established protocols.
- Track GTS/distribution control blocks effectively.
- Conduct User Acceptance Testing (UAT) for RIMS and GTS as required.
- Collaborate with global RA teams and customer service to address issues related to GTS/distribution control blocks and maintain objective evidence.
- Perform gap analysis on existing license master data and create summaries utilizing advanced Excel and other data analysis tools.
- Upload and manage RA data in RIMS and GTS systems using automated tools, troubleshooting data discrepancies as necessary.
- Utilize technical expertise in data mining and modeling tools to derive insights from distribution control data for RA and recommend enhancements to existing processes.
- Understand software validation and testing protocols.
- Comprehend medical device regulations and their applications.
- Grasp distribution, logistics, and order flow from various Enterprise Resource Planning (ERP) systems to GTS.
- Provide training to team members on maintaining data integrity tools and techniques.
- Assist in the development of training materials and work instructions.
- Preferred experience with global regulatory systems.
- Experience with data mining tools and advanced Excel skills is advantageous.
- Strong written, verbal, and interpersonal communication skills.
- Excellent problem-solving and analytical abilities.
- Capacity to learn and apply regulations relevant to medical devices, biologics, drugs, and combination products.
- Familiarity with EU, EMEA, APAC, LATAM, or US regulations related to medical devices, biologics, drugs, and combination products.
- Attention to detail and ability to work in an organized, consistent manner.
- Proficiency in SAP modules, SAP GTS, ERP systems, Microsoft Office Suite, Adobe Professional, and Excel for data analytics.
- Bachelor's degree (or equivalent) required; concentration in life sciences, technical/engineering, or related field preferred.
- Proficiency in English is required (C1). Knowledge of Portuguese is preferred.
- A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or a related field is required.
EOE/M/F/Vet/Disability
-
Regulatory Compliance Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Galderma A tiempo completoCompany Overview: Galderma stands as a leader in dermatology, boasting a rich history and a commitment to innovation. Our presence spans approximately 90 countries, delivering a diverse range of premium brands and services in the dermatology sector, including Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our inception in 1981, we...
-
Regulatory Compliance Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Galderma A tiempo completoCompany Overview: Galderma stands as a leader in dermatology, boasting a rich history and a commitment to innovation. Our presence spans approximately 90 countries, offering a diverse range of premium brands and services across Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Our mission is to enhance the health and beauty of skin,...
-
Regulatory Compliance Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Galderma A tiempo completoCompany Overview: Galderma stands as a pioneering leader in dermatology, boasting a rich history and a commitment to innovation. With a presence in around 90 countries, we offer a diverse range of science-driven products and services that cater to the dynamic dermatology market, including Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology....
-
Global Regulatory Compliance Expert
hace 5 días
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoAbout the RoleZimmer Biomet is a global medical technology leader, and we're committed to enhancing patient mobility and quality of life. As a Regulatory Affairs Systems Specialist, you'll play a critical role in supporting our mission.Key ResponsibilitiesSupport Business Unit Regulatory activities, including publishing, filing, establishment registrations,...
-
Regulatory Affairs Systems Specialist
hace 5 días
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoAbout This RoleZimmer Biomet is a global medical technology leader, dedicated to enhancing patient mobility and quality of life. As a key member of our team, you will play a critical role in supporting our mission by ensuring compliance with regulatory requirements for our medical devices.Key ResponsibilitiesSupport the maintenance and implementation of...
-
Regulatory Affairs Systems Specialist
hace 6 días
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoAbout the RoleZimmer Biomet is a global medical technology leader dedicated to enhancing patient mobility and quality of life. As a Regulatory Affairs Systems Specialist, you will play a critical role in supporting the maintenance and implementation of regulatory systems, with a focus on Regulatory Information Management System (RIMS) and Regulatory...
-
Regulatory Affairs Specialist
hace 2 días
Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo**About Us**Galderma is a leading dermatology company with a rich legacy and a commitment to innovation. We are dedicated to advancing dermatology for every skin story.**Job Summary**We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for implementing regulatory programs,...
-
Regulatory Affairs Systems Analyst
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoAt Zimmer Biomet, we are dedicated to advancing innovation and fulfilling our mission. As a prominent leader in medical technology for nearly a century, a Zimmer Biomet product or technology enhances a patient's mobility every 8 seconds. As a member of the Zimmer Biomet team, you will contribute to our mission of providing mobility and renewed life to...
-
Regulatory Affairs Systems Analyst
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoAt Zimmer Biomet, we are dedicated to advancing innovation and fulfilling our mission. As a leading entity in medical technology for nearly a century, a Zimmer Biomet product or technology enhances a patient's mobility every 8 seconds. As a member of the Zimmer Biomet team, you will participate in our dedication to providing mobility and renewed life to...
-
Regulatory Compliance Specialist for LATAM
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Vantage Specialty Chemicals A tiempo completoCompany OverviewVantage Specialty Chemicals is a prominent provider of naturally sourced specialty ingredients and formulations designed to meet the dynamic demands of both industrial and consumer markets. Our commitment to innovation, customer satisfaction, and a global presence positions us as a leader in enabling tomorrow's solutions today.Position...
-
Regulatory Affairs Specialist
hace 2 días
Bogotá, Bogotá D.E., Colombia Galderma A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma. As a key member of our regulatory team, you will be responsible for implementing regulatory affairs programs, processes, and policies to support our product regulatory activities.Key ResponsibilitiesDevelop and implement regulatory affairs programs and...
-
Bogotá, Bogotá D.E., Colombia Kellanova A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Senior Head Pacific to lead our regulatory compliance activities in the Pacific region. As a key member of our team, you will be responsible for ensuring compliance with current regulations and providing regulatory counselling to internal and external stakeholders.Key ResponsibilitiesRegulatory...
-
Regulatory Compliance Specialist for LATAM
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Vantage Specialty Chemicals A tiempo completoCompany OverviewVantage Specialty Chemicals is a premier provider of naturally sourced specialty ingredients and formulations designed to meet the dynamic demands of both industrial and consumer markets. Our commitment to innovation, customer-centricity, and a global presence positions us as a leader in enabling future solutions today.Position PurposeThe...
-
Regulatory Affairs Specialist
hace 2 días
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoAbout Zimmer BiometZimmer Biomet is a global medical technology leader with a rich history of innovation and commitment to improving patient outcomes. With a presence in nearly 100 countries, our products and technologies enhance patient mobility and quality of life.Our MissionWe are dedicated to providing mobility and renewed life to people around the...
-
Regulatory Affairs Systems Analyst
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoAbout Zimmer BiometAt Zimmer Biomet, we are dedicated to advancing innovation and fulfilling our mission. As a leading global medical technology company for nearly a century, our products enhance patient mobility every 8 seconds.As a member of the Zimmer Biomet team, you will contribute to our mission of providing mobility and renewed life to individuals...
-
Regulatory Compliance Specialist for LATAM
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Vantage Specialty Chemicals A tiempo completoCompany OverviewVantage Specialty Chemicals is a prominent provider of naturally sourced specialty ingredients and formulations tailored to meet the dynamic demands of both industrial and consumer sectors. Our commitment to innovation, customer satisfaction, and a global presence positions us as a leader in enabling tomorrow's solutions today.Position...
-
Regulatory Affairs Systems Analyst
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoAt Zimmer Biomet, we are dedicated to advancing innovation and fulfilling our mission. As a prominent leader in medical technology for nearly a century, a Zimmer Biomet product or technology enhances a patient's mobility every 8 seconds. As a member of the Zimmer Biomet team, you will contribute to our commitment to providing mobility and renewed life to...
-
Bogotá, Bogotá D.E., Colombia Kellanova A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Senior Head Pacific to lead our regulatory compliance activities in the Pacific region. As a key member of our Regulatory team, you will be responsible for ensuring compliance with current regulations for our multi-category portfolio across Pacific countries.Key ResponsibilitiesRegulatory Compliance:...
-
Regulatory Affairs Systems Analyst
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoAt Zimmer Biomet, we are dedicated to advancing innovation and fulfilling our mission. As a prominent player in the global medical technology sector for nearly a century, our products enhance patient mobility every 8 seconds. Joining Zimmer Biomet means being part of a team committed to improving mobility and restoring lives worldwide. We prioritize...
-
Regulatory Affairs Specialist
hace 19 horas
Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completoAbout Zimmer BiometZimmer Biomet is a global medical technology leader dedicated to enhancing patient mobility and quality of life. With a rich history spanning nearly 100 years, our company has been at the forefront of innovation, driving advancements in medical technology that make a meaningful difference in people's lives.Our MissionWe are committed to...
