Manager, Regional Compliance (Based in São Paulo)

Reposted 10 Days Ago
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São Paulo
In-Office
Senior level
Healthtech • Pharmaceutical
The Role
Manage compliance for LATAM activities by providing operational support, training, communication, and consultation to ensure adherence to healthcare regulations and improve efficiency.
Summary Generated by Built In

At Edwards Lifesciences, we’re committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards’ high ethical standards and continue to enable us to transform patient lives around the world.

How you´ll make an impact
  • Coordinate compliance business operational support as part of the EMEACLA Compliance Solutions team with specific focus on LATAM activities and regional Training & Communication activities.

  • End-to-end compliance management, review and approval of transactions and engagements with HCPs and HCOs across various business activities, including providing consultative advice and support to business stakeholders.

  • Provide appropriate guidance to internal stakeholders on compliance processes and procedures; Implement and provide input to simplify processes, systems, and procedures across the region to ensure ongoing assessment and improvement in compliance effectiveness and resource allocation.

  • Lead centralized training & communication plan and curriculum for EMEACLA region. Develop communication and training materials such as job aids, interactive digitalized e-learning and other resources for internal stakeholders; update such resources as required; centrally track participation and completion of the compliance training requirements in EMEACLA.

  • Conduct data analysis from various systems and platforms to track key metrics; assist global compliance team in performing EMEACLA monitoring activities as required

  • Support transparency reporting obligation in timely manner and with adequate quality focused on LATAM Region.

  • Provide pragmatic Compliance support to LATAM business stakeholders and Legal & Compliance lead.

What you will need
  • Bachelor’s degree in law, finance, business administration or related field

  • 5+ years of experience

  • Previous experience in Compliance and/or Legal required

  • Excellent knowledge of English and Portuguese; intermediate Spanish communication skills

  • Previous experience with LATAM

  • Proven expertise in MS Office Suite (e.g., Word, Outlook, Excel, PowerPoint) required; Experience in JDE or SharePoint preferred

  • Excellent knowledge of reporting procedures and record keeping

  • An analytical mind able to “see” the complexities of procedures and regulations with strict attention to detail

  • Proven successful project management skills with extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards

  • Intermediate facilitation and presentation skills

  • Experience with digital communication and training methods, including AI usability, as an important plus

  • Excellent creative problem analysis and resolution skills with methodical and diligent approach with outstanding planning abilities

  • Written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

  • Understanding and knowledge of healthcare regulations (e.g., U.S. federal anti-kickback law, OIG Guidelines for Pharmaceutical Manufacturers, U.S Sentencing Guidelines, AdvaMed Code of Ethics and related regional codes of conduct on interactions with health care professionals, Foreign Corrupt Practices Act, UK Anti-Bribery Act and other related laws, rules, and regulations)

  • Understanding and knowledge of Industry Code requirements

  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

  • Ability to manage competing priorities in a fast-paced environment

  • Represent leadership on sections of projects within a specific area interfacing with project managers and compliance team

  • Ability to consult in project setting within specific sections

  • Ability to provide leadership to outsourcing partners on a task level

  • Ability to apply business acumen in advising business partners on complex challenges

  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

  • Ability to develop and maintain strategic partnerships

  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

What else will help you
  • Works independently without close supervision

  • Compares and evaluates possible courses of action after considering various possibilities

  • Applies his or her knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met

  • Considers the cause and effect of activities

  • Determines or effectively recommends course of action after considering potential risks of alternatives

  • May provide guidance to lower and mid-level personnel

  • Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment

  • Direction tends to be high level and focused on end results with means of accomplishment left to incumbent

Top Skills

Jde
Ms Office Suite
Sharepoint
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The Company
Draper, Utah
13,687 Employees
Year Founded: 1958

What We Do

Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.

Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today.

Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives.

Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life.

For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms

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