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Regional Regulatory Affairs Manager (LATAM) Job

Remote Eligible:  Remote in Country
Onsite Locations(s): 

Buenos Aires, B, AR Bogota, CUN, CO San Juan, PR, PR Lima, LIM, PE Mexico, Distrito Federal, MX Santiago, Santiago Metropolitan Region, CL São Paulo, São Paulo, BR San Jose, CR

Additional Locations:  N/A

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Purpose Statement 
    
The role is critical in linking with the executive management team for the country and in the relationships with the competent authorities/health authorities.  Develops and manages a strong relationship with the competent authorities (covering product notifications, materiovigilance, field actions and any other specific program).  Provides regulatory support and expertise to the local organizations.  Manages the impact of the regional and national regulations to the business.  Supports lobbying activities.

 

Key Responsibilities 

  • Regulatory: Secures regulatory approvals according to specific country requirements and applicable laws; Monitors local as well as regional regulatory environment and providing updates to business partners; Supports registration activities of distributors in the country/region; Prepares and executes clinical trial notifications to competent authorities; Communicates with competent authorities on field corrective actions, vigilance etc.
  • Business: Participates in strategic planning for the region providing regulatory input; Maintains an active knowledge of the status of pending approvals and registrations; Provides regulatory related information to business country heads, sales managers and customer services; Participates in regional/country business reviews and provides regulatory input; Supports local customer services and tender specialists in terms of providing regulatory documents, translations, solving regulatory issues; Provides literature and advertising review for locally produced promotional materials; Raises non-compliance issues and business exposures to business country heads and head of RA; Acts as a link to Quality team.
  • Influencing: Builds trusted relationship with competent authorities in the region; Participates in relevant working groups of industry associations; Takes part in lobbying activities either as BSC representative or via industry association.
  • Quality System Requirements 
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

 

Management Requirements 

  • May lead a group or team of employees in the achievement of organizational goals.  Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
  • Job Scope and Leveling Guidelines 

 

Scope 
Accomplishes results through lower level subordinate supervisors or through experienced professional employees who exercise significant latitude and independence in their assignments.  Monitors progress toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility. Receives assignments in the form of objectives with goals. Provides direction to employees according to established policies and management guidance. Often heads a centralized functional activity.

Supervision Received 
Works under minimal supervision. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.

Supervision Provided 
Provides direction and guidance to lower level subordinate supervisors or through experienced professional employees. Acts as an adviser to subordinates and may become actively involved, as required, to meet schedules and resolve problems. Evaluates performance of and assists in career development planning for subordinates.

Job Complexity 
Works on issues of moderate scope where analysis of situations or data requires evaluation of a variety of factors, including an understanding of current business trends. Must have a complete understanding of functional specialty and industry practices, techniques, and standards. Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Acts as an advisor to subordinates to meet schedules and/or resolve technical problems. Develops and administers schedules and performance requirements. May have budget responsibilities.

Policy Involvement 
Interprets and executes policies and procedures that typically affect subordinate organizational units.  Recommends modifications to operating policies. Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments.

Operations Involvement/Direct Work Involvement 
Functions as an advisor to a unit regarding tasks, projects, and operations. Investigates and solves problems that impact work processes and personnel within the assigned unit. Becomes actively involved in daily operations only when required to meet schedules or to resolve complex problems.

Project Involvement 
Manages projects of small to moderate scope including schedules, scope, costs and resources. May participate in cross-function teams.

Planning and Organization 
Creates immediate to mid-range plans to carry out objectives established by top management. Schedules human and material resources within a group or section in conjunction with plans to ensure their availability; carries out operations within an established budget.

Impact 
Assignments are expressed in the form of tasks and objectives; generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management. Ensures that projects are completed on schedule and within budget.  Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time, human resources, and funds.

Influence and Leadership 
Promotes the attainment of group goals by selecting, motivating, and training capable staff. Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.

Liaison 
Frequently interacts with subordinate supervisors, functional peer groups and/or customers. Interacts with various management levels concerning operations or scheduling of specific phases of projects or contracts. Conducts briefings and participates in technical meetings for internal and external representatives concerning specific projects, operations or schedules. Interaction normally requires the ability to gain cooperation of others.

What we are looking for in you: 

  • At least 10 years of experience in medical device Regulatory Affairs; at least 5 years of experience in supporting commercial regulatory strategies in Latin America.
  • Understanding of the Healthcare ecosystem of Latin America, with at least 5 years of experience working based on any Latam country.
  • Knowledge and exposure to the Latin America region. Awareness and understanding of its challenges and opportunities.
  • Execution and iniciative driven individual. Highly analytical.
  • Strong communication skills.
  • Ability to think strategically and innovatively
  • Learning agility and emotional intelligence to adapt and respect cultural differences.
  • Proven leadership skills to motivate and influence teams that do not report directly into the role across latam. Also proven ability to influence and collaborate with senior leaders of the Region.
  • Able to work as alone and as part of a team
  • Preferred finance knowledge to understand the impact of commercial terms in short and long term P&L variables.
  • Full proficiency of the Spanish and/or Portuguese language and high proficiency of English.
  • Expertise in (e.g. digital/software, clinical studies etc. ) …., will be advantageous.

****This postition will be hired in any of the following countries: Mexico, Puerto Rico, Colombia, Costa Rica, Peru, Argentina, Brazil, Chile.***

 

Requisition ID: 517501

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


Job Segment: Medical, Regulatory Affairs, Law, Regional Manager, Manager, Healthcare, Legal, Management

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