Product Surveillance Analyst

hace 4 semanas

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 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 semanas

    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 semanas

    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 for regulatory...

  • Post Market Surveillance Specialist

    hace 2 semanas

    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 2 semanas

    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 semanas

    Bogota, Colombia Zimmer Colombia A tiempo completo

    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...

  • Post Market Surveillance Specialist, Gbs

    hace 4 semanas

    Bogota, Colombia Zimmer Biomet A tiempo completo

    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...

  • Product Analyst

    hace 3 semanas

    Bogota, Colombia Quorum Business Solutions A tiempo completo

    **Product Analyst** **Location: Bogotá, Colombia** **Model of Work: Hybrid** Are you excited by challenges? Do you enjoy working in a fast-paced, international, and dynamic environment which contributes to drive the energy transition? Then now is the time to join Quorum Software, a rapidly growing technology & professional services solutions company and...

  • Upstream IT Product Manager en Resistance

    hace 2 semanas

    Bogota, Colombia bioMérieux A tiempo completo

    Entreprise 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 3 semanas

    Bogota, Colombia Encora A tiempo completo

    At 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...

  • Commercial Quality Analyst

    hace 3 semanas

    Bogota, Colombia Johnson & Johnson A tiempo completo

    Johnson & Johnson MedTech is recruiting for a Commercial Quality Analyst, located in Bogotá Colombia. Responsible for ensure compliance with J&J policies and procedures described in the Quality Management System applicable to the Marketing Company, distribution channels and requirements indicated by Local Quality Regulations. Establishes and maintains...

  • Product Accounting Analyst

    hace 4 semanas

    Bogota, Colombia BNP Paribas A tiempo completo

    PRODUCT 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 1 mes

    Bogota, Colombia DiDi Global A tiempo completo

    Company 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...

  • Credit Analyst, Structured Finance

    hace 7 días

    Bogota, Colombia Fitch Ratings A tiempo completo

    Credit Analyst, Structured Finance - Colombia **Requisition ID**:46562**Business Unit**:Fitch Ratings**Category**:Credit Analysis & Research**Location**:Bogota, CO**Date Posted**:May 2, 2024**Analyst - Structured Finance - Colombia** **Fitch Ratings is seeking an Analyst to join its Structured Finance group in Colombia**.- **What We Offer**: - An...

  • Business Product Analyst Ii

    hace 3 semanas

    Bogota, Colombia Telesign A tiempo completo

    **Location: Bogotá-Colombia** **Telesign** is a cloud communications company that is redefining the way the largest brands in the world protect, connect, and engage with their users. With an innovative suite of APIs, enhanced by data intelligence and Machine Learning, Telesign delivers communication, verification, and Mobile Identity solutions that have...

  • Security Intelligence Analyst

    hace 4 semanas

    Bogota, Colombia GMV A tiempo completo

    We 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...

  • Product Accounting Analyst

    hace 4 semanas

    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...

  • Rating Analyst

    hace 2 semanas

    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...

  • Integration Technical Business Analyst

    hace 1 semana

    Bogota, Colombia Factor IT A tiempo completo

    En 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...

  • Senior Business Analyst

    hace 3 semanas

    Bogota, Colombia FullStack Labs A tiempo completo

    FullStack is the fastest-growing software consultancy in the Americas. We help organizations like Uber, GoDaddy, MGM, Siemens, Stanford University, and the State of California, build distributed software development teams, and deliver transformational digital solutions. As an employee-first company, we focus on hiring the most talented software designers and...

  • Commercial Quality Analyst

    hace 4 semanas

    Bogota, Colombia Johnson & Johnson A tiempo completo

    Ensure compliance with J&J policies and procedures described in the Quality Management System applicable to the Marketing Company, distribution channels and requirements indicated by Local Quality Regulations. Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality...