דרושים Regulatory Affairs Specialist Ii Costa Rica ב-Boston Scientific ב-קוסטה ריקה

Academic Background

• Advanced student in Occupational Safety and Environmental Hygiene Engineering or Occupational Health.
• Must be currently enrolled in a university.

Language Skills

• English level: B2 (Upper-Intermediate)

Technical Skills

• Desirable knowledge of Microsoft Office at an intermediate level.

Soft Skills

• Effective communication
• Critical thinking and problem-solving
• Adaptability and flexibility
• Time management
• Initiative and proactivity

Other Requirements

• Availability to complete an internship of 6 to 12 months.
• Must be available to work 30 to 32 hours per week, on-site.

Responsibilities:

• Oversees and prepares IP contract documents from initial stages through execution.
• Reviews, negotiates, drafts, revises, and amends contracts to ensure compliance with Boston Scientific policies and procedures.
• Drafts various agreements including, but not limited to, master services agreements, research agreements, material transfer agreements, and design and development agreements, collaboration agreements, license agreements and data use agreements.
• Coordinates work of various departments and acts as liaison between the Legal Department and external and internal stakeholders.
• Collaborates with departmental staff, legal team, and other personnel involved with contract development and approval processes.
• Manages IP Agreement process and helps to refine and makes recommendations for improvement of processes and procedures related to contracts.
• Partners with IP Attorneys to collaboratively negotiate and manage contracts.
• Provides IP input and IP language into non-IP agreements.

Basic Qualifications

• Bachelor’s degree or equivalent is required.
• Experience with Intellectual Property is preferred.
• Previous experience working in a cross-functional and collaborative business environment.
• Ability to identify and implement process improvement opportunities.
• Fluent in English (spoken and written) required.
• Strong written and verbal communication, with the ability to effectively communicate with leadership.
• Strong problem solving and analytical skills.
• Demonstrates courage in ensuring value-driven solutions are delivered.
• Self-starter, collaborative nature, time management

Costa Rica-Coyol

Responsibilities

• Learns how to work as a Sales Enablement team member to support internal customers through compiling, analyzing, and tracking data.
• Works on specific functional area objectives or projects that may require research, working in teams, developing presentations.
• Assists with filing, data entry, recording and maintaining accurate and complete Sales Enablement records.
• Compiles and analyzes business intelligence information through preparation of reports or journal entries.
• Takes additional tasks or projects to learn more about Sales Enablement and company’s operations.
• Takes an active interest in seeking opportunities for continuous improvement and standardizing processes.
• To support our internal clients by gathering, analyzing, and tracking key data.
• Works on specific projects within functional areas, collaborating on research, presentations, and team efforts.
• You'll contribute to maintaining accurate and complete records of business intelligence, handling filing, data entry, and record-keeping tasks.
• You'll be an integral part of the team, closely collaborating with the Sales Department to support strategic initiatives.

Requirements

Career: Systems Engineer, Computer Engineering, Computer Science, Information Technology, Industrial Engineer, Economist, Statistician

Nice to Have: Programming, Salesforce, Tableau, Power BI

About the role:

This is a highly visible opportunity to serve as the Integration Developer delivering strategic initiatives supporting the HR function. You will own the integration development and implementation responsibilities for our SuccessFactors Integrations product team that designs, develops, tests, deploys, maintains, integrations that flow data to/from our HR platform successfactors. Partnering with HR leadership, and product management team you will be responsible for implementing and supporting various integrations. You’ll work across several globally dispersed teams on some of Boston Scientific’s most critical strategic projects. You will be instrumental in achieving our organization’s goals.

Your responsibilities will include:

• Design and implement integration flows using SAP CPI and BTP.
• Collaborate with functional and technical teams to gather requirements and translate them into integration solutions.
• Develop and maintain APIs and middleware components for HR applications.
• Monitor and troubleshoot integration issues, ensuring high availability and performance.
• Participate in code reviews, testing, and deployment activities.
• Document integration designs, configurations, and support procedures.
• Ensure compliance with data security and privacy standards.
• Ensure that the HR system and related processes meet all applicable compliance requirements
• Ensure adherence to BSC Global Systems methodology and SOX controls
• Ensure Production support tickets are handled within the agreed SLAs
• Work proactively on achieving the VIP goals set for the team.
• Support teams’ growth in Scrum/Kanban methodologies as well as conduct Scrum ceremonies to support enterprise delivery transformation model
• Provide product team reporting/dashboard(s) for senior management in a timely manner

Minimum qualifications:

• Bachelor’s degree in a related field (completed)
• 2+ year of Experience in Design and implement integration flows using SAP CPI and BTP
• 2+ years of Integration Development experience
• Experience in Product Teams and Agile SCRUM methodologies
• Advance English Level

Preferred qualifications:

• Experience in delivering results in large, cross-functional software initiatives
• Experience with SuccessFactors and data integrations processes
• Experience with SuccessFactors implementation and knowledge of different modules in SF
• Experience working on solutions in a controlled environment
• Proficiency in Microsoft Office: Word, Excel, and PowerPoint

About the Role:

Required qualifications: --- MUST.

Preferred qualifications: --- NICE TO HAVE

Númerode la requisición:617388

Como líder en ciencia médica durante más de 40 años, estamos comprometidos a resolver los desafíos que más importan, unidos por un profundo cuidado por la vida humana. Nuestra misión de promover la ciencia de por vida consiste en transformar vidas a través de soluciones médicas innovadoras que mejoran la vida de los pacientes, crean valor para nuestros clientes y apoyan a nuestros empleados y las comunidades en las que operamos. Ahora más que nunca, tenemos la responsabilidad de aplicar esos valores a todo lo que hacemos, como empresa global y como ciudadano corporativo global.

Key Responsibilities

• Lead strategic planning with senior executives to develop a comprehensive business strategy for Costa Rica and Central America, including market mapping and opportunity identification.
• Develop and execute integrated marketing plans to maximize market share, promote new product launches, and build brand awareness and customer loyalty.
• Conduct ongoing market research and competitor analysis to identify new opportunities and monitor market shifts.
• Collect and structure field information for updated market mapping and business sizing.
• Initiate and lead customer programs, networks, and advisory boards.
• Manage and oversee the regional marketing plan and budget.
• Lead and manage new product launches.
• Design and implement conference and symposium strategies to support the regional plan.
• Collaborate with sales managers to ensure sales representatives are adequately trained; organize physician and staff training, patient education events, and monitor post-training results.
• Select, develop, motivate, and retain a high-performing marketing team.
• Work with operations to manage supply chain for products, including forecasting, backorder management, and inventory planning for new products.
• Develop clinical activities plans, including registries and post-market studies.
• Quantify and prioritize reimbursement opportunities and execute related plans.
• Spend approximately 50% of time in the field supporting account conversion, product launches, clinical activities, and market intelligence gathering.
• Maintain regular communication with international/corporate marketing and sales/country management to ensure alignment.
• Ensure alignment with international functions (Finance, Supply Chain, Health Economics, Marketing, Clinical, Regulatory, Quality).
• Ensure compliance with standard operating procedures and champion quality and regulatory commitments.
• Promote quality awareness and guide the organization toward improved performance and customer-oriented initiatives.

What we are looking for in you:

• Bachelor’s degree in Marketing, Business Administration, or a related field.
• Fluent English.
• Experience working in sales organizations. (preferably in medical devices)
• Proven marketing and leadership experience of 5 or more years.
• Thorough practical knowledge of marketing theories, principles, and systems.
• Experience applying business and industry standards to achieve objectives.
• Strong problem-solving skills and ability to adapt plans to meet business challenges.
• Effective decision-making impacting finances, results, and service levels.
• Excellent communication and collaboration skills, with the ability to influence and guide others.

Position Responsibilities:

• Coordinate, compile, and submit regulatory filings for new and modified products to Costa Rica and Central America Health Authorities.
• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings;
• Monitor and assess regulatory updates for compliance with applicable regulations and impact to regulatory filings, communicate relevant changes to internal stakeholders.
• Collaborate cross-functionally with global and regional RA counterparts, legal representatives, commercial, marketing, and operations teams to ensure aligned execution of regulatory priorities and approvals.
• Maintain current and accurate information in regulatory systems regarding status, approvals, and product licenses.
• Develops and maintains positive relationships with regulatory agencies and industry associations through verbal and written communications.
• Coordinates localization process to guarantee Costa Rica and Central America labeling requirements are met.
• Provide regulatory input on promotional, labeling, and advertising materials in line with Central America regulations.
• Serve as the RA point of contact for consultants and distributors to ensure accurate and compliant submissions.

Required Qualifications:

• 3-5 years of experience as a Regulatory Affairs Specialist in medical devices in Costa Rica and Central America countries.
• Knowledge of Central American regulations.
• Bachelor’s degree in Life Sciences (Pharmacy, Biochemistry, Biomedical Engineering or associated areas);
• Advanced English;
• Attention to detail and ability to identify trends, gaps etc.
• Problem-solving skills;
• Ability to communicate complex ideas clearly and simply both verbally and in writing;
• Ability to effectively manage multiple projects and priorities;
• Team player with excellent interpersonal skills.

Preferred Qualifications:

• General knowledge of global or LATAM regulations is an asset.
• Experience with interactions with regulators: Regulatory Intelligence and Advocacy.