Senior Regulatory Affairs Specialist

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.

Senior Regulatory Affairs Specialist

Santa Clara, CA, (Hybrid: Tuesday through Thursday in-office required. Not a remote role)

SI-BONE is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date.

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 compliment key strategic and commercial initiatives.

• In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, ISO14971, IEC 62366), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing. The employee has the responsibility to report any instances to their direct supervisor or above.

• Act and conduct business in an honest, ethical and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code and all applicable laws and regulations, whether national, regional, state or local.

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)

• In conjunction with Head of Regulatory, responsible for communication and correspondence with DEKRA (Notified Body), FDA, and Regulatory bodies (competent authorities)

• Prepare Regulatory submissions such as US Pre-Submissions, 510(k)s and Letter-to-File; and EU / OUS Declarations of Conformity, Technical Files (STEDs), Notice of Changes for new products and product 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 any issues or concerns, and support the Quality System Management Representative, as appropriate

• Facilitate communication, Regulatory-related remediations, and written audit responses to the responsible regulatory agency

• Oversee labeling, including product labels, implant cards, IFUs, surgical technique manuals, cleaning and sterilization instructions, etc., ensuring compliance to standards, guidelines, regulations, company requirements, and regulatory approvals/clearances. Ensures translations have been performed per in country requirements.

• Communicate with RA consultants (e.g. Emergo), Authorized Representative and sometimes directly with International regulatory bodies (competent authorities) to obtain approvals and manage registrations

• Monitor and obtain information regarding FDA clearances/approvals of competitors and proactively share information

• Support Regulatory-related activities for Sustaining Operations, including product changes, supplier changes, CAPAs, Deviations, NMRs, and extension/scope changes

• Write and/or review Quality Manual, SOPs, WIs, Forms that impact the QMS

• Support the SI-BONE Quality System

Knowledge, Educations and Experience:

• Bachelor's degree in a scientific discipline
• 5+ years of directly relevant experience with a minimum of 4 years of recent experience in FDA/cGMP/CE Mark or other regulated environment(s)
• Knowledge of industry standards and regulations (FDA, QSRs, MDR ISO 13485, MEDDEV, MDCG etc.)
• Knowledge and familiarity of applicable regulations/standards (e.g. ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971) as required to perform the job function.

Expertise and Attributes:

• Experienced in Quality System requirements such as Design Control, Production Process Controls, Supplier Controls, Corrective and Preventive Action, and Non-Conformances

• Regulatory experience within the medical device industry preparing PreSubmissions, 510(k)s submissions and STEDs is required

• Strong writing, communication, organizational and computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat (for submission E-copies)

• Strong oral, written, organizational and computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) 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

Salary range: $120,000 - $130,000. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors.

Supplemental pay: bonus and stock

There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit www.si-bone.com/risks.

We are aware of active recruitment scams using the SI-BONE name, in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note, we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses, which contain "@si-bone.com" to communicate with candidates.

If you believe you've been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at https://www.cisa.gov/be-cyber-smart/report-incident learn how to report it.