דרושים Clinical Specialist ב-Boston Scientific ב-South Korea, Yongin-si

[Purpose Statement]

To support all Health economics and Market access (HEMA) activities enabling BSC products to be launched onto the market in the shortest possible time and at the best possible price. To identify, obtain, analyze and generate clinical outcomes, health economics and reimbursement information in support of health economics and reimbursement strategies for BSC products.

[Key Responsibilities]

• Reimbursement submission & approval: Prepare reimbursement listing application to demonstrate therapeutic/economic value proposition and achieve the reimbursement approval with the target prices

• Reimbursement strategies and activities: Review and synthesize literature and other sources of information for reimbursement and evidence dossiers for reimbursement

• Create economic and clinical evidence to develop the health economics arguments to support reimbursement approval of new products

• Communicate and keep good relationships with related bodies such as HIRA (Health Insurance Review and Assessment service), NECA (National Evidence based Healthcare collaborating Agency) for the reimbursement process

• Monitor and communicate policy developments that impact the reimbursement success of assigned products

• Maintain up-to-date reimbursement list and compliance and inform it to other divisions in timely manner through regular reporting, plan updates, cross functional meeting

• Actively participate in the government, industry group activities to influence government policy to ensure patient access to new medical technologies

• Communicate with internal and external personnel regarding the reimbursement information such as regulations, reimbursement list and coverage guidelines, etc.

• Training of internal and external personnel for the reimbursement system

[Required Qualifications]

• Bachelor’s degree or higher (Science, Life Sciences-Biology, etc.)

• Fluency in reading, writing and speaking in English

• Ability to understand and communicate regulatory, scientific, and clinical information

• Good communication and cooperation skills

• Passionate and comprehensive thinking

• Good computer proficiency (MS Office – Excel, PowerPoint, Word)

[Preferred Qualifications]

• Over 3 years in regulatory affairs and medical product reimbursement, preferably within Medical Device industry and multinational companies

• Advanced degree (MS, MPH, MHA, MBA) in healthcare, economics, outcomes research

• Deep knowledge of clinical fields and medical devices

• Excellent understanding of product registration regulations and reimbursement

• Experience in systematic review of clinical/literature evidence

[Key Responsibilities]

• Analyze business and customer requirements and develop a customized digital solution/ support to provide the best customer experience and business insight

• Drive and supervise technical solution development and implementation on business platform to utilize digital technologies such as Cloud, AI and automation

• Lead and participate in project and programs including regional/global engaged to improve customer experience, to support E2E SCM process, VOC and process optimization

• Improve OTC process by leveraging digitalization tools, including but not limited to: automating order replenishment process, offering real-time order fulfillment and inventory visibility

• Develop data reports, visualizations, and executive presentations to communicate insights effectively

• Verify and maintain reports and data provided by digital solutions and share reports with cross-functional teams

• Train Sales Representatives, Distributors, and 3PL partners on process updates and systems to foster familiarity with new tools, enhance customer centricity, and improve service and support outcomes

• With the understanding the integrated data flow between applications to timely resolve any potential system or data issues

• Work with multiple teams including internal supply chain team as well as IT team for digital project delivery

[Required Qualifications]

• Bachelor’s degree

• Minimum 7 years of experience in Supply Chain Management

• Experience for build, implement and maintain business databases (platforms) and data management processes

• Good written and verbal communication and interpersonal skills in English

• Strong analytical and problem-solving skills

• Familiar with SAP

• Excellent computer skills (MS Office- Excel and PowerPoint)

[Preferred Qualifications]

• Customer service experience, planning or supply chain specialist Excellent experience

• Proven project experience for implementing supply chain (planning/warehousing/logitics) related best practices by leveraging the power of data

• Excellent communication, interpersonal, and customer service skills

• Demonstrate competency in Inventory Management

Sr. Regulatory Affairs Specialist is responsible for leading regulatory submission strategies, ensuring compliance with applicable regulations, and serving as a key liaison between local authorities, global RA teams, and internal stakeholders. This role requires in-depth regulatory knowledge, project leadership skills, and the ability to guide junior team members.

1. Regulatory Strategy & Submission Management

• Develop and prioritize strategies for regulatory approvals, including new product registrations, license renewal, license re-evaluation, and KGMP certifications (excl. KGMP recertification), for assigned product lines
• Ensure timely submissions and approvals through high-quality regulatory applications aligned with planned or committed timelines
• Collaborate with global and regional RA peers to align strategies and provide timely regulatory support
• Serve as a regulatory consultant to the marketing team, offering input to support business objectives

2. Compliance Across Product Lifecycle

• Ensure regulatory compliance throughout the product lifecycle, including labeling, advertising/promotional material review, and product change management
• Complete all mandatory quality training within designated timelines and ensure compliance with internal quality systems, policies, and applicable local regulations
• Support internal and external audits related to BSK-owned products

3. Regulatory Intelligence & Policy Engagement

• Monitor emerging regulatory trends and assess their potential impact on organizational processes; proactively share relevant updates with internal stakeholders
• Represent the company in local medical device industry associations, collaborating with industry peers to respond to regulatory authorities and contribute to policy development
• Participate in global and local projects to ensure alignment with global processes and adherence to local regulatory requirements

4. Authority & Stakeholder Relationship Management

• Build constructive and trusted relationships with local health authorities through high quality submissions, timely responses to MFDS requests, and well-supported scientific justification, including alternative solutions when appropriate
• Maintain active engagement with industry associations to strengthen BSK’s influence in shaping local regulatory policy

[Required Qualifications]

• Bachelor’s degree in biomedical engineering, life sciences, or a related field
• 7-9 years of hands-on experience in Regulatory Affairs within the medical device industry
• Strong knowledge and understanding of medical device regulations covering pre-market and post-market management
• Excellent written and verbal communication skills in English
• Proven problem-solving and strategic planning skills
• Team player with a proactive attitude and collaborative mindset

[Preferred Qualifications]

• Proficient in MS Office applications (Word, Excel, PowerPoint)
• Familiarity with Digital Medical Product regulations or post-market surveillance requirements

Key Responsibilities

• Cultivate and enhance key account relationships through routine customer visits, product demonstrations, educational programs, product in-services, procedural observation, and problem resolution. Including relationships with physicians, nurses, technicians, materials management, hospital administration, and infection control.
• Partners closely with Territory Managers, Sales Management, HEMA, and other cross functional partners in evaluating business conditions and sales trends.
• Drive utilization of focused technologies
• Clinical excellence in respective disease states.
• Develop and implement a proactive plan that involves service support with Region Manager and team members, to maintain market share and increase the quality of service to customers.
• Assist in the professional education activities sponsored by BSC by participating in on-site and field training workshops.
• Recognize opportunities to communicate and present BSC information to increase sales activities in the region.
• Provide timely updates on business plans to Regional Manager on ongoing business activities, competitive conditions, industry trends, etc.
• Manage expense budget and internally provided promotional budget within guideline.
• Prepares comprehensive plans, by account, which reflects the overall Urology Division strategy.
• Utilization of Salesforce, Tableau, and other sales enablement tools.
• Maintain accurate records of sales expenses, customer files and field sales reports required.
• Submit any required administrative paperwork in a timely manner.
• Conduct all sales activities according to Travel & Entertainment (T&E) guidelines, Advamed Policies and Integrity Policies.
• Occasional weekend and evening trade show and/or meeting participation
• Committed to travel as necessary for position — typically 40-50% travel.

Qualifications

• Self-starter, team player, proven leadership qualities, high coachability
• Ability to determine and set priorities
• Ability to build and maintain strong customer relationships
• Flexibility: Can accept change and is flexible toward change. Have the ability to redirect work and priorities to be in alignment with the strategic corporate goals. Counted on to achieve objectives and be flexible to take on other tasks when required.
• Must be energetic, enthusiastic, determined and goal oriented
• Excels in fast-paced, competitive environment

Preferred Qualifications

• 2+ Business to business sales experience
• Completed sales training program / degree
• Bachelor’s degree
• Must reside in territory

The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

FARAPULSE™ Pulsed Field Ablation System is the world's clinical leader in PFA used in 40,000+ patients and is transforming treatment for atrial fibrillation. The FARAPULSE System is a complete PFA solution, evolving the standard of care for AFib with transformative technology.

Key Responsibilities

• ellElectrophysiologyproducts to achieve the company's monthly/quarterly/yearly goals
• Provideregularcustomer visits to current and potential customers based on professional clinical knowledge to understand the needs and competitive situations of our products and provide appropriate solutions
• Develop andexecutesales strategies for continuous business growth and manage sales of responsible customers
• Manage key customers through in-service/procedural observationsincludingelectrophysiologystudyand radiofrequency/cryo/pulse field ablation performed in the electrophysiology laboratory
• Conduct customer education programs to promote the benefits and proper use of our electrophysiology products and attend related meetings, conferences, andexhibitionon behalf of Boston Scientific
• Respond to customer needs and complaints about products and services by proposing creative and realistic solutions or collaborating with related teams (e.g. Clinical Research, Marketing, etc.)
• Communicate and collaborate with business partners tocreatebusiness growth
• Share best practices and learning experiences with colleagues and teams to contribute to team growth

Basic Requirements

• ’s degree or equivalent field clinical/sales experience
• Passion to learn and dedicate to improve patient’s lives.
• Good written and verbal communication and interpersonal skills.
• Ability to collaborate & communicate with diverse internal and external partners, including across functions, with regional and global partners, and with organizational leadership

Preferable Requirements

• ~ 5 years medical device sales experience (especially preferred EP or CRM field)
• Good verbal and written communication skills in English
• Good computer proficiency (MS Office – Word, Excel and Outlook) preferred

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Hybrid Roles:

About the role

Responsible for

You will be identifying, coordinating, and assigning project priorities based on business and department objectives.Responsible for identifying and implementing continuous improvements to improve product performance and complaint processes. Will help develop and maintain a robust CIS training program.

Your responsibilities include:

• Providing leadership to a team of Quality Technicians & Quality Engineer(s) to champion departmental or cross-functional initiatives. This includes providing direction, coaching, and mentoring to technical team personnel as well as providing guidance on daily work priorities to improve product performance.
• Creating a robust training plan/curriculum for all technicians/engineers
• Creating a pipeline of future hires thru advance planning for talent and onboarding of suitable interns
• Owning and maintaining all departmental SOPs/WIs
• Fostering excellent cross functional communications and collaboration with other functions (Decon. team, CMS, CCC, Sales Support, Patient Care, R&D, Mfg site, others).
• Conducting regular staff and 1-on-1 meetings with direct reports
• Conducting end continuous performance reviews and career development discussions with direct reports
• Implementing a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources
• Assigning relevant trainings to new hire and provide them with technical guidance as needed
• Overseeing effective execution of complaint management WIP and adjusting workloads to maintain green metrics.
• Being responsible for all CIS related metrics
• Maintaining the CIS lab and its equipment as needed
• Actively working with all other CIS locations to ensure effective implementation of best practices.
• Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Post Market organizations
• Fostering a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
• Reviewing and approving timecards for hourly employees
• Conducting annual performance reviews and recommending compensation adjustments annually based on performance demonstrated
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Required Qualifications:

Minimum Qualifications

• Bachelor’s degree with an Engineering or Science background with 5+ years of relevant experience
• Demonstrated problem-solving & data analysis capabilities
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Good verbal and written communication skills
• Ability to multi-task and be adaptive
• English Language 80%
• Please submit Resume in English

Preferred Qualifications

• 5 years of Supervisory experience
• Experience in Medical Device industry

• Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis
• Self-motivated with the ability to identify improvement opportunities
• Efficiently present performance and issues to peer and senior management audiences
• Familiarity with Post Market requirements and systems

Key Responsibilities (90% for the field task / 10% for the office work)

• Actively promote key products through providing comprehensive clinical solutions and having effective collaboration with sales and marketing teams
• Provides ongoing clinical education and a conceptual procedure to maximize IO product’s features & benefits as well as serves as a primary resource for a clinical support in the designated accounts.
• To develop and implement sales& marketingstrategiesbased onthe relevant factors (e.g., products, procedures and competitors) of existing and potential accountsin order topromote the company's products
• To build and manage strong and long-lasting relationships with customers and their stakeholders in assigned territory to ensure appropriate product positioning.
• Responding to customer requirements and seeking their potential needs regarding products and service by developing feasible solutions or working with other stakeholders.
• Observing actual procedures in assigned accounts to gain both practical and academic insights from operators and physician assistants.
• Continue to introduce and position BSC main products to ensure sustainable sales growth

Basic Requirements

• Passion to learn and dedicate to improve patient’s lives.
• Good written and verbal communication and interpersonal skills.
• 2-5years of working knowledge/experience in medical devices/pharm
• especially experience in Peripheral intervention, Interventional oncology, Hepatology, Gastroenterology and General Oncology preferred

Preferable Requirements

• Good verbal and written communication skills in English

Required System Skills

• Good computer proficiency (MS Office – Word, Excel and Outlook) preferred