Regulatory Affairs Specialist

hace 2 semanas


Bogota, Colombia Medtronic A tiempo completo

**Careers that Change Lives**

**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.

**Must Have: Minimum Requirements**
- BA/BS degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience.
- 2 years of relevant experience in regulatory affairs or related areas.
- Fluent English level.
- Strategic thinking.
- Analytical and problem solving skills.
- Document interpretation, queries and workflow skills.
- Strong organization and time management skills.
- Decision making skills.
- Team player.
- Ability to work as a team
- Excellent communication skills.
- Knowledge in SAP.
- Knowledge in MS Office.
- Knowledge in Excel.
- Ability to work in matrix structured organization.

**Nice to Have**
- Presentation skills for small to mid-sized groups.
- Regulatory affairs experience in medical devices or pharmaceutical industry.
- Job experience as Associate Regulatory affairs Specialist.
- High understanding of market and laws for medical devices in Latin-American countries.
- Fluent Portuguese level.

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)



  • Bogota, Colombia Novasyte A tiempo completo

    POSITION TITLE: Regulatory Affairs Specialist REPORTS TO: Manager, Regulatory Affairs or Designee BASIC FUNCTIONS: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance,...


  • Bogota, Colombia SGF Global A tiempo completo

    **Role description** - Coordinate the Regulatory Affairs activities at the export markets (Ecuador, Peru, Venezuela, Bolivia, Paraguay and Uruguay) - Implement and execute Regulatory Affairs processes and policies ensuring that all the aspects of the product safety are closely monitored and fulfil the regulatory requirements through ongoing support and...


  • Bogota, Colombia Unilever A tiempo completo

    Regulatory Affairs Manager - Colombia Diversity is one of our most relevant pillars and our main objective is to develop an internal environment open to the multiplicity of thoughts, through inclusion without stereotypes. This allows us to value the best professionals, bringing together diverse profiles and styles, and better facing the current and future...


  • Bogota, Colombia Abbott Laboratories A tiempo completo

    **Primary Job Function**: Bridge building with key influencers, decision makers, policy makers and KOL´s, including but not limited to, Executive & Legislative branches of power, NGO´s, Federal, State and local authorities, political parties, in order to position Company´s agenda. Participation and leading role within trade and/or industry associations....


  • Bogota, Colombia ABBVIE A tiempo completo

    Join us at AbbVie, where medicine, aesthetics, and science are powered by some of the brightest minds in the world. We're a dynamic biopharmaceutical company that offers you the resources you need and a global reach that empowers your innovative mindset. From day one, we've known it takes teamwork, passsion, and culture built on diversity and inclusion to...


  • Bogota, Colombia Yara A tiempo completo

    Date posted: Aug 26, 2023- Location: Bogota, Bogotá D.C., CO- Job Function: Sales & Marketing- Job Type: Permanent- Job Requisition ID: 17206**Communications specialist**: **About the Unit**: Yara offers solutions for sustainable agriculture and the environment. Our fertilizers and crop nutrition programs help produce the food needed by the world's growing...


  • Bogota, Colombia AstraZeneca A tiempo completo

    Contributes to multiple Regional Corporate Affairs and communications projects to help AstraZeneca communicate important corporate messages to internal and external stakeholders - Contributes to engagements with key internal or external groups, such as sales teams, external charities, government lobbyists and regulators - Carries out research, either...


  • Bogota, Colombia IQVIA A tiempo completo

    **Join us as a **Site Activation Specialist**!**: **Job Overview**: **IQVIA’s Country Site Activation team are a global network who identify and activate sites to the highest quality to ensure patients on Clinical trials have access to safe and effective medication. We are leaders in innovation and first to new technologies meaning a vast amount of career...

  • EHS Specialist

    hace 6 días


    Bogota, Colombia JLL A tiempo completo

    JLL supports the Whole You, personally and professionally. What this job involves We are currently seeking a dynamic individual for the role of EHS Specialist to join our team: **Location**: Bogota, Colombia. **Work schedule**: Monday to Friday, 8:00 am to 5:00 pm. **Work model**: On site **Contract Type**: Indefinite-term What is your day to day? Work...


  • Bogota, Colombia inDrive A tiempo completo

    Colombia, Bogota - Hybrid - Full-time - Middle - We are looking for a professional in Government Relations, who will be providing support in coordinating the company's interaction with public authorities in Colombia. **Tasks and duties are to**: - Prepare and execute licensing plans for all the Company's branches of business in Colombia; - Coordinate...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    Johnson & Johnson MedTech is recruiting for a(n) COMMERCIAL QUALITY SPECIALIST, located in Bogotá Colombia. Responsible for supporting end-to-end quality operations within the North Cluster, ensuring compliance with J&J policies and procedures outlined within the applicable quality management system at Johnson & Johnson. Establishing/maintaining quality...


  • Bogota, Colombia Twilio A tiempo completo

    **See yourself at Twilio**: Join the team as our next Channels Onboarding Operations Specialist (English & Portuguese). **Who we are & why we're hiring**: Although we're headquartered in San Francisco, we have presence throughout South America, Europe, Asia and Australia. We're on a journey to becoming a globally anti-racist, anti-oppressive, anti-bias...


  • Bogota, Colombia AbbVie A tiempo completo

    **Company Description** About AbbVie** The Market Access Regional TA Head, Intercon reports to the Market Access TA Director, Intercon. They must work in strong partnership with the Regional Market Access Director, aligned to the region’s objectives. This person will serve as a strategic partner to relevant TA, as well as relevant global, Intercon and...

  • Channel Specialist

    Encontrado en: Talent CO C2 - hace 2 semanas


    Bogota, Colombia Roche A tiempo completo

    The Position Our Vision Our vision is to make CX as transformative as our science and be known for consistently creating seamless customer experiences that are as innovative and impactful as our medicines. This is why we are evolving the LATAM Omnichannel team - to make this a reality by integrating digital and face-to-face interactions seamlessly...


  • Bogota, Colombia Rappi A tiempo completo

    ¡Oye, es hora de que te unas a nosotros para mostrarle al mundo que somos la empresa que está cambiando paradigmas, donde revolucionamos las horas, los minutos y los segundos! ¿Quieres saber por qué Rappi? - ️ VEMOS OPORTUNIDADES donde otros ven problemas; - ️ VEMOS CERCANIA donde otros ven distancia; - ️ VEMOS ADRENALINA donde otros ven...


  • Bogota, Colombia B. Braun Medical S.A. A tiempo completo

    Tendrá la responsabilidad de diseñar e implementar las estrategias de mercadeo y ventas para lograr el posicionamiento, cuota de mercado y rentabilidad adecuados del portafolio de productos de la unidad de negocio bajo su responsabilidad a nível nacional y de las terapias asignadas **Obligaciones y responsabilidades**: - Diseñar e implementar...


  • Bogota, Colombia BT A tiempo completo

    **TITLE: Regional Delivery Specialist (RDS)** **Location: Colombia** **Career Level E** **Hiring Manager Kari,B,Birgit,JSDA R** **Talent Acquisition contact name Israel Paniagua** *** **Why BT?** We’ve always been an organisation with purpose; to use the power of communications to make a better world. You can trace this back to our beginning as...


  • Bogota, Colombia MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck/MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally.Acts...


  • Bogota, Colombia TransUnion A tiempo completo

    TransUnion's Job Applicant Privacy Notice **What We'll Bring**: We are looking for a great communicator to join the Corporate Affairs and Communications team of TransUnion to support the marketing communications needs of our Global Capability Center (GCC) in Costa Rica. Part of a larger global team, this role will implement best practices in a fast-growing...

  • Sales Training Manager

    hace 3 días


    Bogota, Colombia Allergan Aesthetics A tiempo completo

    **Company Description** At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service,...