דרושים Safety Program Specialist ב-Boston Scientific ב-Costa Rica, Heredia

Costa Rica-Heredia

Hybrid Roles:

Your responsibilities include:

• Project/Program Management: Manages key initiating, planning, executing, controlling, and closing processes; develops and implements project plan; builds team ownership and commitment to project plan. Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort. Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project. Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans. Identifies and manages project dependencies and critical path items while ensuring project quality and utilizing and following appropriate methodologies (e.g. PLCP). Assures project quality by using standard development methodologies. o Communicates project status by preparing standard status reports, and by participating in project status update meetings. Resolves project issues by working with team members, project customers, and others as appropriate. Consults with internal project groups by sharing project management knowledge. Conducts project post mortems and communicates lessons learned in order to identify successful and unsuccessful project elements. Participates in external project management organizations, conferences and seminars to keep current with industry best practices in project management by joining professional associations and implementing a professional development plan with focus on project management.
• Led cross-functional, multi-dimensional product development teams from concept through Launch; through proper execution of design controls that include an efficient transfer of newly developed products from Global R&D to manufacturing and global marketing through the BSC-defined PDLC processes to achieve project closure.
• Acts as liaison with other functions/sties for projects site is a contributor or stakeholder in.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.

What We’re Looking For:

• Licenciature degree or above in Mechanical Engineering, Electrical Engineering or Field Related.
• English Level required: C2:(95-100%).
• Desired knowledge: Risk Management/ Risk Mitigation, Program Management, External Regulations (p.e. Quality, Systems) Master Degree in PM or equivalent, PMI certified PM.
• At least 10 years of experience in similar position.
• Please submit Resume in English\

Costa Rica-Coyol

About the role:

The Program Safety Specialist II is responsible for managing adverse events, device reporting, and safety deliverables for investigational and marketed products in the Rhythm Management division. This includes authoring and ensuring the execution of project-specific safety plans and overseeing event and complaint processing in accordance with study-specific operational plans.

Your responsibilities will include:

• Develop and author study-specific safety documents and plans (e.g., Safety Plan, Complaint Plan, CEC/IMR Charter).
• Assess the type and level of processing required for adverse events.
• Manage adverse event processing, including report reviews, safety query resolution, and expedited reporting.
• Perform medical review and assessment of adverse events in clinical trials.
• Participate as a core team member in clinical study teams.
• Lead Clinical Trial Safety Review meetings.
• Ensure adjudication and reconciliation of safety events prior to data snapshots, as applicable.
• Provide safety-related input for study documents and processes (e.g., protocol development, CRF design).
• Ensure timely delivery of functional safety outputs to support study milestones.
• Oversee additional projects and deliverables within and outside the department as needed.

Required Skills:

• Effective verbal and written communication skills.

• Strong analytical kills for identifying and addressing safety-related issues.
• Exceptional organizational and time management skills to prioritize tasks and meet deadlines.

Required qualifications:

• Bachelor’s degree (or equivalent) nursing, science or related field.
• Minimum of 3 years in clinical/scientific research, medical device, or clinical trials experience.
• Advance English Level
• Please submit resume in English

Preferred qualifications:

• Knowledge of device therapies in Electrophysiology, Watchman and Rhythm Management.
• Experience in processing and assessing safety events in clinical trials.
• Familiarity with Good Clinical Practice (GCP) guidelines.
• Knowledge of applicable safety regulations, including ISO 14155 and 21 CFR 812.

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!

Costa Rica-Heredia

Your Responsibilities:

• Cross functional collaboration and review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory submissions
• Liaise with International BSC Regulatory Affairs colleagues on product and manufacturing changes to support information requests and international submissions
• Support the coordination, writing, and submission of U.S. and EU regulatory submissions for modified products and manufacturing changes
• Maintain EU MDR Technical Documentation

• Represent RA on cross functional project teams
• Participate in corporate and department training

Minimum Requirements:

• Minimum of a bachelor’s degree or related field
• 2+ years regulatory affairs or related experience
• Ability to collaborate with cross-functional team members to gain understanding of technical information through thoughtful questioning and engagement with team members
• Ability to communicate technical information and complex ideas clearly and succinctly both orally and in writing
• Demonstrated ability to effectively manage multiple projects and priorities and execute in a timeline driven environment
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
• Advance English Level

Your responsibilities include:

• Manage TRS and the training system of direct personnel under his/her area of responsibility.
• Provide the initial orientation of new hire direct personnel.
• Organize and coordinate activities of trainers from his/her area of responsibility.
• Engage in transfer processes in order to coordinate trainers and training activities required, as well as TRS.

Required Qualifications:

• Bachelor’s degree in Industrial Engineering or related, Business Administration
• English intermediate (B1+ / 60 - 69%)
• No previous experience required
• Experience with Microsoft Office
• Availability to work on Shift A, B or C.

Desired Qualifications

• TRS
• Windchill
• MES
• Medical Industry preferred
• Previous experience managing teams

603718

Costa Rica-Heredia

Your Responsibilities:

• Cross functional collaboration and review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory submissions
• Liaise with International BSC Regulatory Affairs colleagues on product and manufacturing changes to support information requests and international submissions
• Support the coordination, writing, and submission of U.S. and EU regulatory submissions for modified products and manufacturing changes
• Maintain EU MDR Technical Documentation

• Represent RA on cross functional project teams
• Participate in corporate and department training

Minimum Requirements:

• Minimum of a bachelor’s degree or related field
• 2+ years regulatory affairs or related experience
• Ability to collaborate with cross-functional team members to gain understanding of technical information through thoughtful questioning and engagement with team members
• Ability to communicate technical information and complex ideas clearly and succinctly both orally and in writing
• Demonstrated ability to effectively manage multiple projects and priorities and execute in a timeline driven environment
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
• Advance English Level