Boston Scientific
Regulatory Affairs Specialist III - Urology
Boston Scientific, Irvine, California, United States, 92616
Regulatory Affairs Specialist III - Urology
Work mode: Hybrid Onsite Location(s): Irvine, CA, US, 92602 Additional Location(s): US-CA-Irvine; US-CA-Valencia; US-MA-Marlborough; US-MN-Maple Grove 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 this role: At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work. We offer a collaborative culture that values diversity and prioritizes initiatives that promote awareness and inclusion, celebrating personal, cultural, and demographic differences of our customers, patients, and workforce. In the Urology division, we continually advance the quality of patient care with innovative Urology solutions. We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position supporting our rapidly growing active implantable device portfolio. This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies. The role requires strong US, EU, and international regulatory experience that can be leveraged to help support international expansion. In this role, you'll be part of a high-functioning, close-knit Regulatory Affairs team responsible for support of submissions and on-going regulatory compliance through partnership with our global R&D, manufacturing, clinical, and quality teams. This position will begin with an onsite onboarding period of approximately 90 to 120 days. Following that, it will transition to a hybrid work model, requiring a minimum of three days per week in the office. The role is ideally based in Irvine, CA, but we are also open to candidates located near our sites in Valencia, CA; Maple Grove, MN; or Marlborough, MA. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time. Your responsibilities will include: Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed Supports the coordination, drafting, and submitting of U.S. and EU regulatory filings for new and modified Class III products Provides technical reviews of test protocols and reports Assesses labeling materials, including Instructions for Use Represents RA on cross functional project teams Works as liaison with International BSC Regulatory colleagues on various projects, including providing support with international regulatory filings Supports highly technical or major business segment product lines, special projects or strategic initiatives Required Qualifications: A minimum of a Bachelor's Degree in a scientific, technical, or related discipline A minimum of 4 years Regulatory Affairs experience in the medical industry Prior experience with 510(k) submissions, EU MDR or international regulatory registrations Preferred Qualifications: Prior experience with PMA submissions or Class III submissions Prior experience with active implantable devices, active devices, or long-term implants. Working knowledge of FDA, EU and international regulations for medical devices General understanding of product development process, design control and quality system regulations Ability to simultaneously manage several projects Proficiency with Microsoft Office Effective research and analytical skills Effective written and oral communication, technical writing and editing skills Ability to work independently with minimal supervision
Work mode: Hybrid Onsite Location(s): Irvine, CA, US, 92602 Additional Location(s): US-CA-Irvine; US-CA-Valencia; US-MA-Marlborough; US-MN-Maple Grove 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 this role: At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work. We offer a collaborative culture that values diversity and prioritizes initiatives that promote awareness and inclusion, celebrating personal, cultural, and demographic differences of our customers, patients, and workforce. In the Urology division, we continually advance the quality of patient care with innovative Urology solutions. We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position supporting our rapidly growing active implantable device portfolio. This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies. The role requires strong US, EU, and international regulatory experience that can be leveraged to help support international expansion. In this role, you'll be part of a high-functioning, close-knit Regulatory Affairs team responsible for support of submissions and on-going regulatory compliance through partnership with our global R&D, manufacturing, clinical, and quality teams. This position will begin with an onsite onboarding period of approximately 90 to 120 days. Following that, it will transition to a hybrid work model, requiring a minimum of three days per week in the office. The role is ideally based in Irvine, CA, but we are also open to candidates located near our sites in Valencia, CA; Maple Grove, MN; or Marlborough, MA. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time. Your responsibilities will include: Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed Supports the coordination, drafting, and submitting of U.S. and EU regulatory filings for new and modified Class III products Provides technical reviews of test protocols and reports Assesses labeling materials, including Instructions for Use Represents RA on cross functional project teams Works as liaison with International BSC Regulatory colleagues on various projects, including providing support with international regulatory filings Supports highly technical or major business segment product lines, special projects or strategic initiatives Required Qualifications: A minimum of a Bachelor's Degree in a scientific, technical, or related discipline A minimum of 4 years Regulatory Affairs experience in the medical industry Prior experience with 510(k) submissions, EU MDR or international regulatory registrations Preferred Qualifications: Prior experience with PMA submissions or Class III submissions Prior experience with active implantable devices, active devices, or long-term implants. Working knowledge of FDA, EU and international regulations for medical devices General understanding of product development process, design control and quality system regulations Ability to simultaneously manage several projects Proficiency with Microsoft Office Effective research and analytical skills Effective written and oral communication, technical writing and editing skills Ability to work independently with minimal supervision