SI-BONE
Overview
SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy. Location : Santa Clara, CA (4 days in-office required. Not a remote role) SI-BONE® focuses on helping patients with sacroiliac (SI) joint conditions. The iFuse Implant System® provides a less invasive alternative to SI joint fusion surgery and has been used in over 90,000 procedures to date. We are seeking people who are passionate about our mission and who are willing to work hard to achieve it. We value agility, creativity and teamwork: Agile: We work in a fast-paced environment and need to learn and adapt quickly. Creative: We embrace creativity and are not afraid to challenge the status quo. Team Players: We roll up our sleeves and work together to achieve our goals. General Responsibilities
Prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International). Maintain existing approvals/clearances and documentation. Manage projects to complement key strategic and commercial initiatives. In cases of potential non-compliance with applicable standards or regulations (e.g., FDA QSRs, ISO 13485, ISO 14971, IEC 62366), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing and must report any instances to their direct supervisor or above. The employee must act and conduct business honestly, ethically and legally, complying with the Code of Conduct, company policies, the AdvaMed Code and all applicable laws and regulations. Specific Responsibilities and Skills
Support New Product Development on project teams on behalf of RA, developing and implementing Regulatory strategies and deliverables for US, EU and International (OUS) Communicate with EU Notified Body, FDA, and other Regulatory bodies (competent authorities) in cooperation with the Head of Regulatory Prepare regulatory submissions such as US Pre-submissions, 510(k)s and Letter-to-File; EU/OUS Declarations of Conformity, Technical Files (STEDs), and Notices of Changes for new products and changes Review product changes for impact on current clearances and approvals Implement new regulations and changes to US and global Regulatory requirements (e.g., EU MDR) Attend internal and external audits/inspections in a Regulatory capacity and address issues or concerns; support the Quality System Management Representative as appropriate Facilitate regulatory-related remediations and written audit responses to the responsible Regulatory agency Oversee labeling (labels, implant cards, IFUs, surgical technique manuals, cleaning and sterilization instructions) ensuring compliance; ensure translations are performed per country requirements Communicate with RA consultants (e.g., Emergo), Authorized Representative and sometimes directly with international regulatory bodies to obtain approvals and manage registrations Monitor and obtain information regarding FDA clearances/approvals of competitors and share information proactively Support Regulatory-related activities for Sustaining Operations (product changes, supplier changes, CAPAs, Deviations, NMRs, and extension/scope changes) Write and/or review SOPs and WIs that impact the QMS Support SI-BONE QMS Knowledge, Education and Experience
Bachelor’s degree in a scientific discipline 6+ years of directly relevant experience with a minimum of 5 years in medical devices/FDA/cGMP/CE Mark or other regulated environments Knowledge of industry standards and regulations (FDA, QSRs, MDR ISO 13485, MEDDEV, MDCG, etc.) Experience with Quality System requirements such as Design Control, Production Process Controls, Supplier Controls, CAPA, and Non-Conformances Strong oral, written, organizational and computer skills including Microsoft Office and Adobe Acrobat for FDA E-copies Thorough understanding of FDA and international medical device regulations, product development process and design control requirements Ability to work independently with minimal supervision and manage multiple projects Must be a team player Important : This is not a remote role. Candidates must reside in the SF Bay Area. Compensation : Salary range: $129,000 - $147,000. The range is location-specific and reflects the factors considered in compensation decisions. Supplemental pay: bonus and stock Risks and Disclaimers
There are potential risks associated with the iFuse Implant System. The information provided here is not a guarantee of outcomes. For more information, visit the company site at www.si-bone.com/risks. We are aware of recruitment scams using the SI-BONE name. SI-BONE will never require payment or cashing checks for employment offers. All official communications use a @si-bone.com email address. If you suspect a scam, report it to the appropriate authorities. How to Apply
Interested in building your career at SI-BONE, Inc? Get future opportunities sent straight to your email. Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Website Are you currently eligible to work in the United States? * Select... Will you now or in the future require sponsorship for employment visa status? * Select... Please see the California Consumer Privacy Policy and acknowledge review of CPRA notice. * Select... Please provide your most recent company information. Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion is voluntary. Information will be kept confidential and used for equal employment opportunity reporting. We do not discriminate on the basis of protected status. This section is intended to comply with VEVRAA and OFCCP requirements. Disabled veteran Recently separated veteran Active duty wartime or campaign badge veteran Armed forces service medal veteran PUBLIC BURDEN STATEMENT: This collection is voluntary and the form provides information required by law. This survey should take about 5 minutes to complete.
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SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy. Location : Santa Clara, CA (4 days in-office required. Not a remote role) SI-BONE® focuses on helping patients with sacroiliac (SI) joint conditions. The iFuse Implant System® provides a less invasive alternative to SI joint fusion surgery and has been used in over 90,000 procedures to date. We are seeking people who are passionate about our mission and who are willing to work hard to achieve it. We value agility, creativity and teamwork: Agile: We work in a fast-paced environment and need to learn and adapt quickly. Creative: We embrace creativity and are not afraid to challenge the status quo. Team Players: We roll up our sleeves and work together to achieve our goals. General Responsibilities
Prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International). Maintain existing approvals/clearances and documentation. Manage projects to complement key strategic and commercial initiatives. In cases of potential non-compliance with applicable standards or regulations (e.g., FDA QSRs, ISO 13485, ISO 14971, IEC 62366), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing and must report any instances to their direct supervisor or above. The employee must act and conduct business honestly, ethically and legally, complying with the Code of Conduct, company policies, the AdvaMed Code and all applicable laws and regulations. Specific Responsibilities and Skills
Support New Product Development on project teams on behalf of RA, developing and implementing Regulatory strategies and deliverables for US, EU and International (OUS) Communicate with EU Notified Body, FDA, and other Regulatory bodies (competent authorities) in cooperation with the Head of Regulatory Prepare regulatory submissions such as US Pre-submissions, 510(k)s and Letter-to-File; EU/OUS Declarations of Conformity, Technical Files (STEDs), and Notices of Changes for new products and changes Review product changes for impact on current clearances and approvals Implement new regulations and changes to US and global Regulatory requirements (e.g., EU MDR) Attend internal and external audits/inspections in a Regulatory capacity and address issues or concerns; support the Quality System Management Representative as appropriate Facilitate regulatory-related remediations and written audit responses to the responsible Regulatory agency Oversee labeling (labels, implant cards, IFUs, surgical technique manuals, cleaning and sterilization instructions) ensuring compliance; ensure translations are performed per country requirements Communicate with RA consultants (e.g., Emergo), Authorized Representative and sometimes directly with international regulatory bodies to obtain approvals and manage registrations Monitor and obtain information regarding FDA clearances/approvals of competitors and share information proactively Support Regulatory-related activities for Sustaining Operations (product changes, supplier changes, CAPAs, Deviations, NMRs, and extension/scope changes) Write and/or review SOPs and WIs that impact the QMS Support SI-BONE QMS Knowledge, Education and Experience
Bachelor’s degree in a scientific discipline 6+ years of directly relevant experience with a minimum of 5 years in medical devices/FDA/cGMP/CE Mark or other regulated environments Knowledge of industry standards and regulations (FDA, QSRs, MDR ISO 13485, MEDDEV, MDCG, etc.) Experience with Quality System requirements such as Design Control, Production Process Controls, Supplier Controls, CAPA, and Non-Conformances Strong oral, written, organizational and computer skills including Microsoft Office and Adobe Acrobat for FDA E-copies Thorough understanding of FDA and international medical device regulations, product development process and design control requirements Ability to work independently with minimal supervision and manage multiple projects Must be a team player Important : This is not a remote role. Candidates must reside in the SF Bay Area. Compensation : Salary range: $129,000 - $147,000. The range is location-specific and reflects the factors considered in compensation decisions. Supplemental pay: bonus and stock Risks and Disclaimers
There are potential risks associated with the iFuse Implant System. The information provided here is not a guarantee of outcomes. For more information, visit the company site at www.si-bone.com/risks. We are aware of recruitment scams using the SI-BONE name. SI-BONE will never require payment or cashing checks for employment offers. All official communications use a @si-bone.com email address. If you suspect a scam, report it to the appropriate authorities. How to Apply
Interested in building your career at SI-BONE, Inc? Get future opportunities sent straight to your email. Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Website Are you currently eligible to work in the United States? * Select... Will you now or in the future require sponsorship for employment visa status? * Select... Please see the California Consumer Privacy Policy and acknowledge review of CPRA notice. * Select... Please provide your most recent company information. Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion is voluntary. Information will be kept confidential and used for equal employment opportunity reporting. We do not discriminate on the basis of protected status. This section is intended to comply with VEVRAA and OFCCP requirements. Disabled veteran Recently separated veteran Active duty wartime or campaign badge veteran Armed forces service medal veteran PUBLIC BURDEN STATEMENT: This collection is voluntary and the form provides information required by law. This survey should take about 5 minutes to complete.
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