Boston Scientific
Overview
Additional Location(s):
US-MN-Arden Hills 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
This position plays a critical role in advancing Boston Scientific's groundbreaking Atrial Fibrillation technology—the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System was the first PFA technology to receive CE Mark approval in Europe and represents a transformative innovation with the potential to shape the future of ablation therapy worldwide. Role and responsibilities
As a Regulatory Affairs Specialist III, you will plan, manage, and implement regulatory submissions to the US FDA, EU notified bodies, and support worldwide product registrations. You will also ensure ongoing compliance with regulatory agency approvals, including leading change impact reviews, while partnering with cross-functional teams to bring innovative therapies to patients around the globe. Work model, sponsorship, relocation
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities
Support the development of domestic and international strategies for regulatory approval of Class I, II, and III medical devices. Represent Regulatory Affairs on cross-functional projects, including product development, manufacturing process changes, and continuous improvement efforts. Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations. Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR. Support international regions to gain and maintain product approvals. Contribute to continuous improvement of departmental and divisional quality through collaboration, best practices, and knowledge sharing. Support regulatory audits, as required. Qualifications
Required qualifications: Bachelor's degree. Minimum of 3 years' experience in Regulatory Affairs or a related discipline within medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling). Demonstrated experience authoring and supporting a variety of regulatory submissions for US and EU, such as PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR. Proficiency with submission and presentation-related computer skills, including Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. Preferred qualifications: Previous experience in the medical device industry with Class II or III device submissions. General understanding of the product development process and design controls. Working knowledge of FDA, EU, and international regulations. Ability to thrive in fast-paced, cross-functional team environments. Strong project management skills, with the ability to manage multiple priorities. Effective research and analytical skills. Strong written and oral communication, technical writing, and editing skills. Experience with Boston Scientific capital equipment and/or single-use sterilized devices. Additional information
Requisition ID:
615058 Salary range:
Minimum $76,000; Maximum $144,400 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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. 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. So, choosing a career with Boston Scientific isn't just business, it's personal. 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! Boston Scientific is an equal opportunity employer. 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. Please be advised that certain US-based positions require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview process if the role requires proof of vaccination as a condition of employment. Boston Scientific will comply with all applicable state and federal laws and healthcare credentialing requirements as policies evolve.
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Additional Location(s):
US-MN-Arden Hills 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
This position plays a critical role in advancing Boston Scientific's groundbreaking Atrial Fibrillation technology—the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System was the first PFA technology to receive CE Mark approval in Europe and represents a transformative innovation with the potential to shape the future of ablation therapy worldwide. Role and responsibilities
As a Regulatory Affairs Specialist III, you will plan, manage, and implement regulatory submissions to the US FDA, EU notified bodies, and support worldwide product registrations. You will also ensure ongoing compliance with regulatory agency approvals, including leading change impact reviews, while partnering with cross-functional teams to bring innovative therapies to patients around the globe. Work model, sponsorship, relocation
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities
Support the development of domestic and international strategies for regulatory approval of Class I, II, and III medical devices. Represent Regulatory Affairs on cross-functional projects, including product development, manufacturing process changes, and continuous improvement efforts. Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations. Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR. Support international regions to gain and maintain product approvals. Contribute to continuous improvement of departmental and divisional quality through collaboration, best practices, and knowledge sharing. Support regulatory audits, as required. Qualifications
Required qualifications: Bachelor's degree. Minimum of 3 years' experience in Regulatory Affairs or a related discipline within medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling). Demonstrated experience authoring and supporting a variety of regulatory submissions for US and EU, such as PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR. Proficiency with submission and presentation-related computer skills, including Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. Preferred qualifications: Previous experience in the medical device industry with Class II or III device submissions. General understanding of the product development process and design controls. Working knowledge of FDA, EU, and international regulations. Ability to thrive in fast-paced, cross-functional team environments. Strong project management skills, with the ability to manage multiple priorities. Effective research and analytical skills. Strong written and oral communication, technical writing, and editing skills. Experience with Boston Scientific capital equipment and/or single-use sterilized devices. Additional information
Requisition ID:
615058 Salary range:
Minimum $76,000; Maximum $144,400 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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. 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. So, choosing a career with Boston Scientific isn't just business, it's personal. 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! Boston Scientific is an equal opportunity employer. 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. Please be advised that certain US-based positions require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview process if the role requires proof of vaccination as a condition of employment. Boston Scientific will comply with all applicable state and federal laws and healthcare credentialing requirements as policies evolve.
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