Product Surveillance Analyst
hace 4 meses
-Requisition Number
AMER28185
Employment Type
Full-time
Location
Bogota
**Job Summary**:
- This position effectively manages complaints for the formally designated unit responsible for complaint management. This includes gathering pertinent details of the complaint event such as patient and product information. Assessing each complaint event for regulatory reporting requirements and creating regulatory reports for submission to FDA or Regional Competent Authority within regulatory timeframes. Closing investigated complaints within a timely manner. This role will also escalate high severity events and cases to Management and proposes solutions to day-to-day processing issues and enhancement opportunities**Principal Duties and Responsibilities**:
- Adheres to all corporate and site specific procedures.
- Documents and maintains records in accordance with corporate and site specific procedures.
- Gathers pertinent details of the complaint event.
- Assesses complaint events for regulatory reporting requirements.
- Submits regulatory reports to FDA or Regional Competent Authority within regulatory timeframes.
- Supports the completion of complaint activities in line with department metrics and key performance indicators.
- Supports and trains team members on complaint process.
- Supports audits and audit requests for complaints.
- Participates in complaint approval function. Assists Management in special projects as required.
**Expected Areas of Competence**:
- Strong organizational and time management skills.
- Strong written, oral, and presentation communication skills.
- Detail-oriented.
- Ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform simple analyses with accuracy.
- Strong decision making skills and proven ability in balancing priorities among the many ongoing tasks, and being responsive to critical situations, as this position has a high volume of work, regulatory mandated time limits, and often changing priorities.
- Action-orientated: Ability to take initiative to correct problems or make changes for improvement without waiting for direction.
- Proven ability to work in a team setting. Willing to share the load and participate in projects outside of normal job scope. Ability to work closely with others to assure functional commitments is met.
- Proven ability to provide training to Team Members as needed. Ability to work with all individuals in a congenial and cooperative manner.
**Education/Experience Requirements**:
- Bachelor of Science degree in biology, health sciences, engineering, or nursing preferred or Bachelor’s degree in another discipline with equivalent years of relevant experience.
2+ years’ experience required, preferably in the medical device industry.
- **Travel Requirements**:
- 5%
-
Trade Surveillance Analyst
hace 4 meses
Bogota, Colombia Credicorp Capital A tiempo completo**¡Súmate a nuestro equipo Credicorp Capital!** En **Credicorp Capital** buscamos Talento** **para ocupar la posición de **Trade Surveillance Analyst **para trabajar en el área de regulación de mercado de la oficina de representación en Colombia de un broker dealer americano. **Si tienes el siguiente perfil, esta oportunidad es para ti**: -...
-
Product Surveillance Analyst
hace 4 meses
Bogota, Colombia Zimmer Biomet A tiempo completo**Requisition Number**: AMER28185 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: This position effectively manages complaints for the formally designated unit responsible for complaint management. This includes gathering pertinent details of the complaint event such as patient and product information. Assessing each complaint event...
-
Post Market Surveillance Specialist
hace 4 meses
Bogota, Colombia Zimmer Biomet A tiempo completo**Requisition Number**: AMER27850 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: The Post Market Surveillance Specialist is document owner for Post Market Surveillance Activities; will document PMS Plans and, if the case, PMS Reviews (PSURs or PMSRs) records according to the applicable regulations (including MDR (EU) 2017/745); he...
-
Post Market Surveillance Specialist
hace 4 meses
Bogota, Colombia Zimmer Biomet A tiempo completo-Requisition Number AMER27850 Employment Type Full-time Location Bogota **Job Summary**: - The Post Market Surveillance Specialist is document owner for Post Market Surveillance Activities; will document PMS Plans and, if the case, PMS Reviews (PSURs or PMSRs) records according to the applicable regulations (including MDR (EU) 2017/745); he /she will be...
-
Post Market Surveillance Specialist, Gbs
hace 4 meses
Bogota, Colombia Zimmer Biomet A tiempo completoAt 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...
-
Post Market Surveillance Specialist, Gbs
hace 4 meses
Bogota, Colombia Zimmer Colombia A tiempo completoAt 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...
-
Upstream IT Product Manager en Resistance
hace 3 meses
Bogota, Colombia bioMérieux A tiempo completoEntreprise familiale, bioMérieux est un **acteur mondial dans le domaine du diagnostic **_in vitro_**. Depuis 60 ans, partout dans le monde, nous concevons et développons des **solutions diagnostiques innovantes** pour **améliorer la santé des patients et des consommateurs**. Aujourd'hui, nos équipes sont présentes dans 45 pays et servent 160 pays...
-
Senior Product Analyst
hace 4 meses
Bogota, Colombia Encora A tiempo completoAt Encora we are looking for a great talent like you to join our team as the next **Senior Product Analyst (4453)** Would you like to join our great team of engineers? Here we will tell you more about us and the role! **About the role**: As a **Senior Product Analyst**, you will be part of a highly skilled technology and agile team by supporting and...
-
Product Accounting Analyst
hace 4 meses
Bogota, Colombia BNP Paribas A tiempo completoPRODUCT ACCOUNTING ANALYST (JOB NUMBER: FIN003679) **About BNP Paribas**: BNP Paribas is a leading bank in Europe with an international reach. It has a presence in 74 countries, with more than 192,000 employees, including more than 146,000 in Europe. The Group has key positions in its three main activities: Domestic Markets and International Financial...
-
Product Marketing Analyst
hace 4 meses
Bogota, Colombia DiDi Global A tiempo completoCompany Overview: DiDi Global Inc. is the world’s leading mobility technology platform. It offers a wide range of app-based services across markets including Asia-Pacific, Latin America and Africa, including ride hailing, taxi hailing, chauffeur, hitch and other forms of shared mobility as well as auto solutions, food delivery, intra-city freight, and...
-
Security Intelligence Analyst
hace 4 meses
Bogota, Colombia GMV A tiempo completoWe are expanding our teams in the cibersecurity sector to take on banking projects. We´ll get to the point; we'll tell you what's not on the web. If you want to know more about de GMV **WHAT CHALLENGE WILL YOU BE TAKING ON?** In our team you will fill the position of Intelligence analyst for obtaining information, filtering and classification to obtain...
-
Rating Analyst
hace 4 meses
Bogota, Colombia S&P Global A tiempo completo**About the Role**: **Grade Level (for internal use)**: 09 **The Role**: Rating Analyst **Grade ( relevant for internal applicants only )**: 9 **The Location**: Bogotá, Colombia. **T he Team**: Rating Analyst is a n Individual Contributor, but this position should be a team player building strong relationship with the team. **The Impact**: Responds to...
-
Product Accounting Analyst
hace 4 meses
Bogota, Colombia BNP Paribas A tiempo completo**About BNP Paribas**: BNP Paribas is a leading bank in Europe with an international reach. It has a presence in 74 countries, with more than 192,000 employees, including more than 146,000 in Europe. The Group has key positions in its three main activities: Domestic Markets and International Financial Services (whose retail-banking networks and financial...
-
Product Data Analyst
hace 4 meses
Bogota, Colombia Sezzle A tiempo completo**Company** Sezzle is a cutting-edge fintech company whose mission is to financially empower young consumers. Our payment platform increases purchasing power for consumers by offering interest-free installment plans. This increase in purchasing power for consumers leads to increased sales for the hundreds of merchants that currently work with...
-
Integration Technical Business Analyst
hace 3 meses
Bogota, Colombia Factor IT A tiempo completoEn FactorIT estamos buscando a un **Integration Technical Business Analyst** con facilidad para trabajar en equipo, comunicación efectiva y flexible. **Requisitos**: - Inglés intermedio (Hablado y escrito)(excluyente) - 5+ años en experiência en ciclo de vida del desarrollo de software - 5+ años ejecutando roles como Lider Agile/Project - Cloud...
-
System Analyst
hace 3 meses
Bogota, Colombia Atlantic Talent Services A tiempo completoThe System Analyst role involves crafting requirements and ensuring their effective implementation throughout the entire process. This includes conducting meetings with stakeholders to comprehend and document their needs, as well as guaranteeing the successful reception of developments by clients. The System Analyst also ensures the seamless integration of...
-
Integration Technical Business Analyst
hace 3 meses
Bogota, Colombia Factor IT A tiempo completoEn FactorIT estamos buscando a un **Integration Technical Business Analyst** con facilidad para trabajar en equipo, comunicación efectiva y flexible. **Requisitos**: - 5+ años en experiência en ciclo de vida del desarrollo de software - 5+ años ejecutando roles como Lider Agile/Project - Cloud Native - Certificación de metodología ágil (Business...
-
Product Support Analyst
hace 4 meses
Bogota, Colombia CSG A tiempo completoColombia, Remote Hi, I'm Juliana Restrepo , your Recruiter. At CSG, we choose to see beyond a resume paper. We put your story, perspective, background, and what you have to offer first. While the traditional approach works for some, many miss out on fantastic talent like yourself, and we refuse to make that mistake. Instead, we believe that by channeling...
-
Product Owner Ba Software Oil Gas
hace 4 meses
Bogota, Colombia Sophos Solutions A tiempo completoSolidez financiera, estabilidad laboral, crecimiento profesional y multiculturalidad; somos una empresa con presencia a nível mundial desde Latam USA e india nos especializamos en soluciones de software con socios como Mambu, Oracle, Microsoft o AWS. Te invitamos a integrarte como Product Owner o Business Analyst Bilingüe con experiência en sector...
-
Product Owner/business Analyst
hace 4 meses
Bogota, Colombia Globant Commerce Studio A tiempo completo**Company Description** Globant’s Commerce Studio helps organizations create best-in-class commerce-enabled experiences, with engineering and design at its core. The goal is to meet the demands of tomorrow's customers, leveraging long-standing expertise with large and complex commerce transformations in both B2B and B2C domains. As an award-winning...
