Regulatory Affairs Coordinator

hace 2 meses

Bogotá Cundinamarca, Colombia Convatec A tiempo completo

**What will you do?**
- Collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings.
- Provides direction regarding the quality requirements of Convatec 's new and marketed products, as well as helping support the implementation of long term companywide quality strategies and operating principles/practices.
- Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.

**About the job**

Responsible for the planning, deployment and execution of Regulatory Affairs and Quality in Distribution strategies in Andean Region of Latin America ensuring that it aligns with the company's strategy and business objectives.

**Duties and Responsibilities**
- Be the main stakeholder of the Company on the applicable regulatory requirements in the region Andean, being vigilant with the regulatory environment of these markets and guaranteeing that a Regulatory strategy is defined on time to support the business
- Guarantee compliance with health regulations and corporate policies applicable to regulatory and quality processes and procedures in Andean Region, as priorities Colombia, Peru, Ecuador and distribution too.
- Act as technovigilance responsible and perform the proper reports internally and externally
- Perform regulatory intelligence, critically evaluating trends and data bringing topics that can impact processes and products of Convatec in Andean region to internal conversations
- Enroll INVIMA, Digemid, ARCSA, ANDE and other similar chambers trainings, workshops and events to learn, get updates and productive benchmark
- Support the reports of claims and non-conformities from detection to investigation and the conclusion of cases
- Coordinate quality processes in distribution and warehouses in Andean to the correct alignment of regulatory content of labels and proper local activities
- Perform adequate regulatory evaluation of claims and projects that require new sanitary registrations or their alteration, supporting the business in all applicable requirements, submission pathways and estimated approval timelines
- Attend to specific and routine trainings, as well as the work tools required for the proper exercise of their functions
- Use the adequate flow of communication in the Latin America regulatory team and Global teams & internal and local areas and distributors supplying documentation and information required
- Align the Regulatory strategy and activities with business strategies, seeking adequate interaction and communication with commercial areas and other functional areas and mitigating risks in Andean
- Define work priorities according to business needs and legal deadlines and inputs of leadership
- Launch purchase requests/orders to develop its activities, monitor expenses in alignment with the annual budget defined and highlight any inconsistence
- Define the annual plan of regulatory records and documentations in the region, monitoring their progress, supporting specific needs of the distributors and helping in the solution of any difficulties to achieve their objectives.

**What are we looking for?**
- Bachelor’s degree in relevant health-related scientific discipline or an advanced degree in a related field is preferred
- Previous experience of medical device or pharmaceutical companies experience in Regulatory Affairs and Quality Assurance processes in Andean region
- Professional title and credentials to be technical and technovigilance responsible of Convatec in Colombia or Peru
- Skills regarding authoring and compiling registration dossiers as well as other processes according to Andean Health Authorities rules
- Knowledge of the different regulatory entities and quality standards applicable in the region
- Demonstrated ability to partner with the business for the deployment of initiatives
- Good communication skills and interpersonal relationships
- Fluent Spanish and English
- Knowledge of the Office package (MS Word, MS Excel, MS Powerpoint)

**Preferred Qualifications**
- Experience interacting with relevant trade associations or serving on trade association committees.
- Quality Auditor background
- We are proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against based on disability._

**Beware of scams online or from individuals claiming to represent Convatec**

**Equal opportunities**

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or vete

  • Regulatory Affairs Specialist

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Join Our Team as a Regulatory Affairs CoordinatorGalderma is a leading dermatology company with a rich legacy and a commitment to innovation. We are seeking a highly skilled Regulatory Affairs Coordinator to join our team.About the RoleThis is an exciting opportunity to work in a dynamic and fast-paced environment, supporting the development and...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Join Galderma's Team as a Regulatory Affairs CoordinatorGalderma, a leading dermatology company, is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a Regulatory Affairs Coordinator, you will play a critical role in implementing regulatory programs, processes, and policies to support our product regulatory activities.Key...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Join Galderma's Team as a Regulatory Affairs CoordinatorGalderma, a leading dermatology company, is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our Regulatory Affairs department, you will play a crucial role in implementing regulatory programs, processes, and policies to support our product regulatory...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Join Galderma's Team as a Regulatory Affairs CoordinatorGalderma, a leading dermatology company, is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our Regulatory Affairs department, you will play a crucial role in ensuring compliance with regulatory requirements and supporting the development of innovative...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Join Our Team at GaldermaWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team at Galderma, a leading dermatology company with a rich legacy and a commitment to innovation. As a Regulatory Affairs Coordinator, you will play a critical role in implementing regulatory programs, processes, and policies to support our activities related...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Join Galderma's Team as a Regulatory Affairs CoordinatorGalderma, a leading dermatology company, is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our Regulatory Affairs department, you will play a crucial role in ensuring compliance with regulatory requirements and supporting the development of innovative...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Join Our Team at GaldermaWe are seeking a highly skilled Regulatory Affairs Analyst to join our team at Galderma, a leading dermatology company. As a Regulatory Affairs Analyst, you will play a critical role in ensuring the compliance of our products with regulatory requirements and ensuring the timely delivery of all information related to the management of...

  • Regulatory Affairs Specialist

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    {"h1": "Join Galderma's Regulatory Affairs Team", "p": "At Galderma, we are committed to advancing dermatology for every skin story. As a Regulatory Affairs Coordinator, you will play a critical role in implementing regulatory programs, processes, and policies to support our innovative products and services.Your key responsibilities will include: *...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    At Galderma, we are seeking a highly skilled Regulatory Affairs Analyst to join our team. As a key member of our regulatory team, you will be responsible for implementing regulatory affairs programs, processes, and policies to support regulatory activities related to product regulatory, drugs CMC regulatory, regulatory operations, and scientific & medical...

  • Regulatory Affairs Specialist

    hace 2 meses

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    About 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...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo

    About Zimmer BiometZimmer Biomet is a global medical technology leader with a rich history of innovation and commitment to enhancing patient mobility.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a critical role in ensuring compliance with regulatory...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo

    About Zimmer BiometZimmer Biomet is a global medical technology leader with a rich history of innovation and a commitment to improving the quality of life for people around the world. Our team members are part of a company that is shaping the future of healthcare and alleviating pain.What to ExpectAs a Regulatory Affairs Specialist, you will be responsible...

  • Regulatory Affairs Coordinator

    hace 5 meses

    Bogotá, Colombia Galderma A tiempo completo

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo

    Join Zimmer Biomet's TeamZimmer Biomet is a leading medical technology company with a rich history of innovation and a commitment to improving the quality of life for people worldwide.What to ExpectA dynamic and collaborative work environmentOpportunities for professional growth and developmentA chance to work on cutting-edge medical technologiesImpact You...

  • Regulatory Affairs Specialist

    hace 6 días

    Bogotá, Bogotá D.E., Colombia Werfen A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to support the implementation and execution of regulatory and quality plans for products marketed by Werfen.Key ResponsibilitiesEnsure compliance with regulatory and quality record management processes.Lead and manage non-conformities, follow-up plans for CAPAs.Document tracking and...

  • Regulatory Affairs Specialist

    hace 5 días

    Bogotá, Bogotá D.E., Colombia Werfenlife SA. A tiempo completo

    As a key member of the Werfenlife SA. team, you will play a vital role in ensuring the quality and regulatory compliance of our medical devices. Your expertise in Quality Assurance and Regulatory Affairs will be instrumental in supporting the implementation and execution of regulatory and quality plans.Key Responsibilities:Support RAQA management with a...

  • Regulatory Affairs Specialist

    hace 4 días

    Bogotá, Cundinamarca, Colombia AbbVie A tiempo completo

    **Company Description** **Major Responsibilities**: - Provides strategic direction to support the development of compliant and competitive Regulatory programs; - Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines to drive complete and timely information to Health Authorities; - Effectively...

  • Regulatory Affairs Analyst

    hace 5 meses

    Bogotá, Colombia Galderma A tiempo completo

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...

  • Regulatory Affairs Specialist

    hace 7 días

    Bogotá, Bogotá D.E., Colombia Experian A tiempo completo

    At Experian, we're looking for a skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will play a crucial role in evaluating legal aspects during the development of new products and the execution of existing ones. Your expertise in data protection and privacy will help us navigate the complex regulatory landscape...

  • Regulatory Affairs Specialist Clinical Trials

    hace 4 días

    Bogotá, Bogotá D.E., Colombia Clínica Colombia ES A tiempo completo

    About the PositionClínica Colombia ES is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bogota, Colombia. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the successful planning and execution of clinical trials and the regulatory approval of new drugs.Key Responsibilities:Regulatory Document...