Regulatory Affairs Coordinator
hace 4 meses
**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
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