Boston Scientific
Senior Regulatory Affairs Specialist - Urology
Boston Scientific, Irvine, California, United States, 92616
Senior Regulatory Affairs Specialist - 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 the role: The Boston Scientific Urology business unit provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. These conditions account for more than 50 percent of all urology surgical procedures. The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies. 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: Develops and implements regulatory strategies for new and modified products. Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams, monitors proposed and current US and EU regulations and guidance, and advises on the impact of such regulations Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations Tracks timelines and documents milestone achievements for inclusion in regulatory submissions Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers, technical files, and international submissions) Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes Trains to departmental and divisional policies and procedures Supports highly technical or major business segment product lines such as combination products, sterilization processes and other special projects or strategic initiatives Fosters a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for their area of responsibility Required qualifications: A minimum of a Bachelor's degree, preferably in a scientific or technical discipline A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) Demonstrated experience of the regulatory requirements associated with implantable or active implantable medical devices Prior experience with PMAs for implantable, active implantable medical devices or other Class III Medical Devices Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices Preferred qualifications: Demonstrated experience of regulations applicable to the conduct of clinical trials Prior experience with regulatory submission writing Demonstrated understanding of product development process and design controls Demonstrated knowledge of FDA, EU and/or international regulations Ability to manage several projects simultaneously Effective research and analytical skills Excellent written and oral communication, technical writing and editing skills Ability to work independently with minimal supervision Strong interpersonal and influencing skills Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms)
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 the role: The Boston Scientific Urology business unit provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. These conditions account for more than 50 percent of all urology surgical procedures. The Senior Regulatory Affairs Specialist is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies. 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: Develops and implements regulatory strategies for new and modified products. Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams, monitors proposed and current US and EU regulations and guidance, and advises on the impact of such regulations Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations Tracks timelines and documents milestone achievements for inclusion in regulatory submissions Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers, technical files, and international submissions) Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes Trains to departmental and divisional policies and procedures Supports highly technical or major business segment product lines such as combination products, sterilization processes and other special projects or strategic initiatives Fosters a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for their area of responsibility Required qualifications: A minimum of a Bachelor's degree, preferably in a scientific or technical discipline A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) Demonstrated experience of the regulatory requirements associated with implantable or active implantable medical devices Prior experience with PMAs for implantable, active implantable medical devices or other Class III Medical Devices Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices Preferred qualifications: Demonstrated experience of regulations applicable to the conduct of clinical trials Prior experience with regulatory submission writing Demonstrated understanding of product development process and design controls Demonstrated knowledge of FDA, EU and/or international regulations Ability to manage several projects simultaneously Effective research and analytical skills Excellent written and oral communication, technical writing and editing skills Ability to work independently with minimal supervision Strong interpersonal and influencing skills Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms)