Boston Scientific
Senior Regulatory Affairs Specialist - Urology
Boston Scientific, Irvine, California, United States, 92713
Additional Location(s)
US-CA-Irvine
About the role
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.
Senior Regulatory Affairs Specialist
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.
Work Model
Hybrid: minimum 3 days per week onsite in Irvine, CA.
Your responsibilities
Develop and implement regulatory strategies for new and modified products. Act 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. Provide technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross‑functional teams. Develop and maintain positive relationships with device reviewers through oral and written communications regarding pre‑submission strategy and regulatory pathway development. Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations. Track timelines and document milestone achievements for inclusion in regulatory submissions. Interact with regulatory agencies as part of submission review and on‑site audit support. Review device labeling for compliance with global regulations and recommend appropriate changes. Train to departmental and divisional policies and procedures. Support highly technical or major business segment product lines such as combination products, sterilization processes and other special projects or strategic initiatives. Foster a work environment of continuous improvement supporting BSC’s Quality Policy, Quality System and applicable regulations.
Required qualifications
Minimum of a Bachelor’s degree in a scientific or technical discipline. Minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices. 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. Experience supporting product development and sustaining activities for implantable or active implantable medical devices.
Preferred qualifications
Experience with regulations applicable to clinical trials. Experience with regulatory submission writing. Understanding of product development process and design controls. Knowledge of FDA, EU and/or international regulations. Ability to manage several projects simultaneously. Excellent research, analytical, 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).
Benefits
Boston Scientific offers a competitive total rewards program including base salary, annual bonus target, long‑term incentives, comprehensive medical, dental, vision, 401(k) plan with company match, life and disability insurance, paid time off, and additional benefits available to applicable employees.
Equal Employment Opportunity
Boston Scientific is an equal‑opportunity employer. We celebrate diversity and are committed to inclusion. We provide a workplace where all employees are respected, valued, and included.
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US-CA-Irvine
About the role
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.
Senior Regulatory Affairs Specialist
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.
Work Model
Hybrid: minimum 3 days per week onsite in Irvine, CA.
Your responsibilities
Develop and implement regulatory strategies for new and modified products. Act 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. Provide technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross‑functional teams. Develop and maintain positive relationships with device reviewers through oral and written communications regarding pre‑submission strategy and regulatory pathway development. Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations. Track timelines and document milestone achievements for inclusion in regulatory submissions. Interact with regulatory agencies as part of submission review and on‑site audit support. Review device labeling for compliance with global regulations and recommend appropriate changes. Train to departmental and divisional policies and procedures. Support highly technical or major business segment product lines such as combination products, sterilization processes and other special projects or strategic initiatives. Foster a work environment of continuous improvement supporting BSC’s Quality Policy, Quality System and applicable regulations.
Required qualifications
Minimum of a Bachelor’s degree in a scientific or technical discipline. Minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices. 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. Experience supporting product development and sustaining activities for implantable or active implantable medical devices.
Preferred qualifications
Experience with regulations applicable to clinical trials. Experience with regulatory submission writing. Understanding of product development process and design controls. Knowledge of FDA, EU and/or international regulations. Ability to manage several projects simultaneously. Excellent research, analytical, 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).
Benefits
Boston Scientific offers a competitive total rewards program including base salary, annual bonus target, long‑term incentives, comprehensive medical, dental, vision, 401(k) plan with company match, life and disability insurance, paid time off, and additional benefits available to applicable employees.
Equal Employment Opportunity
Boston Scientific is an equal‑opportunity employer. We celebrate diversity and are committed to inclusion. We provide a workplace where all employees are respected, valued, and included.
#J-18808-Ljbffr