Boston Scientific AF Solutions - Technical Support Chengdu 

China, Sichuan, Chengdu City 

892374862

About this role:

As a part of the Boston Scientific Cardiac Rhythm Management division, you will work to deliver advanced, life-saving and sustaining technologies to patients worldwide. We provide innovative solutions for diagnosing and treating heart conditions, and we’re constantly advancing in crucial areas and expanding our reach into new markets and regions.

In this role, you will be encouraged to be curious, develop and employ creative and critical thinking skills, and will have the opportunity to satisfy your desire to learn about emerging technologies and their impact on the business and organization. Joining the Cardiac Rhythm Management (CRM) Regulatory team at Boston Scientific means you’ll play a pivotal role in delivering cutting-edge technologies that preserve and save lives across the globe.

• At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office in Arden Hills, MN at least three days per week.

• Relocation is not available at this time for this position.

• Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include:

• Supporting the development of global strategies for regulatory approval of Class I, II and III medical devices
• Coordinating, compiling, and submitting U.S. and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
• Assisting with BSC International regulatory requests regarding submissions, registrations, and change assessments; develop and manage relationships with regulatory representatives
• Reviewing product and manufacturing changes to ensure compliance with applicable regulations and impact on regulatory filings
• Supporting regulatory audits as needed
• Reviewing promotional materials for regulatory compliance
• Representing Regulatory Affairs on cross-functional projects such as product development, manufacturing process changes, and continuous improvement
• Assisting with departmental projects such as procedure stewardship, Value Improvement Projects (VIP), and Regulatory Operations initiatives
• Keeping abreast of emerging technologies and potential business and organizational impacts
• Working with clinical affairs on various aspects of clinical trials and clinical reports

Required Qualifications

• Bachelor’s degree in life science, engineering or related disciplines

• 2+ years regulatory or related experience
• Technical writing skills

Preferred Qualifications

• Working knowledge of regulatory requirements for medical devices
• Effective written and oral communication skills
• Strong computer skills with experience using Adobe Acrobat and Microsoft Office applications (Word, Excel, PowerPoint, etc.)
• Experience working with cross-functional teams
• Relevant coursework, work-study, or internship experience with US, EU, and international regulatory requirements for medical devices and quality systems standards
• Ability to work effectively as an individual and as part of a team; ability to recognize and consider varying perspectives
• Experience working directly with US FDA, notified bodies and/or international health authorities

• Demonstrated ability to effectively lead multiple projects and priorities

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

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.