Training Operations Specialist, Clinical Education (Structural Heart)

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- 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.

About the role:

Boston Scientific is seeking a Training Operations Specialist to oversee and enhance our global training programs for Structural Heart Valves (SHV) Clinical Education. In this role, you will play a pivotal part in maintaining high standards of quality and compliance while driving continuous improvements in physician training processes. This is an exciting opportunity to collaborate with cross-functional teams and influence training initiatives that directly impact patient outcomes and the success of cutting-edge medical devices.

The Training Operations Specialistis responsible for maintaining global training programs, quality assurance initiatives, and policies governing the training processes for SHV Clinical Education. In this role, you will collaborate with the Design Assurance, Medical Education, and Clinical Training teams to ensure the effective execution and compliant implementation of physician training, aligned with medical device standards, regulations, and Boston Scientific requirements. Leveraging feedback and data-driven insights, you will drive continuous improvement in training processes. You will also work closely with Marketing, Sales, Clinical, R&D, and Design Assurance teams to assess and meet HCP training needs throughout the product development cycle, from early stages to commercialization.

This hybrid position requires being onsite at our Maple Grove, MN location 3 days per week.

Your responsibilities will include:

• Support compliance oversight of the SHV HCP and internal training programs to meet internal and external regulatory requirements across all applicable geographies
• Monitor the HCP training process for products by establishing compliance metrics and scorecards to ensure effective implementation of the training process and associated records
• Oversee the monthly training records reconciliation process and ensure follow-up on outstanding issues
• Drive training compliance and use feedback to enable data-driven decisions for continuous improvement
• Lead corrective and preventive actions as needed; proactively identify and execute opportunities for preventive measures
• Collaborate cross-functionally to identify and resolve technical and performance issues
• Serve as a subject matter expert on the quality aspects of training for internal and external customers
• Implement and maintain components of a comprehensive training program for Global SHV Training
• Create, support, and execute innovative and engaging training and educational solutions, resources, and tools to align with the Global SHV training strategy and respond to curriculum needs
• Execute projects that support the development and enhancement of training and communication programs spanning multiple regions, divisions, and functions
• Support the training strategy by writing and editing engaging and tailored content for Global Clinical, aligned with the global clinical strategy
• Manage key training projects, including Educare and digital initiatives
• Maintain tools and documentation that reflect operational processes related to training
• Cultivate internal relationships and develop a network of resources to facilitate task completion
• 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.
• 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.

Required Qualifications:

• Bachelor's degree in science, healthcare, engineering, or a related field.
• 5+ years of experience in the medical device, pharmaceutical, or other regulated industry.
• Experience working with quality systems and controlled processes.
• Demonstrated ability to present information clearly and communicate effectively.
• Proven ability to work collaboratively with cross-functional teams.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Experience using data analysis to support decision-making.

Preferred Qualifications:

• Working knowledge of U.S. and international regulations and standards relevant to BSC, including 21 CFR 806 & 820, ISO 13485:2016, MDD, AIMD, MDR, CMDR, RDC, and JPAL.
• Experience in medical education.
• Familiarity with BSC IS systems (e.g., eCAPA, Windchill, APPROVE) preferred.
• Experience collaborating with cross-functional teams such as Regulatory, R&D, Clinical, Medical, Sales Training, and Quality.

Requisition ID:589280

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!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran's status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance freeworkplace. Pursuant to Va. Code * 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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.

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