Regulatory Affairs Coordinator

hace 1 mes

Ciudad de México, Ciudad de México ConvaTec A tiempo completo

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit

What will you do?

Manage/develop the successful coordination, compilation, submission and approval of New Medical Devices, Changes of medical device applications to the LATAM regulatory agencies (Cofepris). This position will work closely with management and cross-functional partners to develop regulatory strategies and various submission packages throughout the development process and through filing and post approval.

  • 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 Mexico and Central 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 subregion Mexico and Centro America, 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 Mexico
  • Support tenders in Mexican market optimizing the flow and availability of necessary documents to application in such biding processes (example technical products datasheets)
  • Act as technical and technovigilance responsible in Mexico
  • Perform regulatory intelligence, critically evaluating trends and data bringing topics that can impact processes and products of Convatec in Mexico to internal conversations
  • Enroll Cofepris, Adimed and other similar chambers trainings, workshop 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 warehouse in Mexico 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 periods
  • 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 LATAM 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 Mexico
  • 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 sub 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
  • 5+ years of medical device or pharmaceutical companies experience in Regulatory Affairs and Quality Assurance processes in Mexico
  • Professional title and credentials to be technical and technovigilance responsible of Convatec in Mexico
  • Skills regarding authoring and compiling registration dossiers as well as other processes according to Cofepris rules
  • Knowledge of the different regulatory entities and quality standards applicable in the sub region
  • Fluent level of English and Spanish
  • Knowledge of the Office package (MS Word, MS Excel, MS Powerpoint)
  • Demonstrated ability to partner with the business for the deployment of initiatives
  • Good communication skills and interpersonal relationships

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

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at *******

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 veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you

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