Program Specialist, Professional Education

SI-BONE, Inc.•Santa Clara, CA

60d•$24 - $36•Onsite

About The Position

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. Program Specialist, Professional Education This is a temp to hire position, local candidates only Headquarters is in Santa Clara, CA. Must be onsite minimum of 3 days a week 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. We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are: Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly. Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo. Team Players: We roll-up our sleeves and work together as one team to achieve our goals.

Requirements

Served as a Program Specialist / Event Planner of a high-growth, medical device organization whose products are marketed to a medical specialty practice and worked in that capacity for a minimum of 3 years. Experience in orthopedics is highly desired, spine experience also a plus
A high level of professionalism, integrity, and discretion in handling confidential information
Strong organization and communication skills with the ability to multi-task effectively, with great attention to detail
Ability to follow through, work independently, take ownership of assigned responsibilities and deliver high-quality work within tight timelines
Willingness to roll up your sleeves to get stuff done, support several projects at one time, and to accept re-prioritization as necessary
Be a pro-active person who attacks problems, displaying initiative and perseverance in order to bring about meaningful change, and to be open and responsive to new ideas
Support or manage logistics associated with launching or supporting new or existing programs
Assist in the development of meaningful metrics to appraise department performance and surgeon adoption rates
Sound knowledge of all Microsoft Office programs and Salesforce
Confidently interact with coworkers and hospital personnel in all relevant departments, including but not limited to physicians, executives and both clinical and non-clinical staff members
Have a strong cross-disciplinary understanding of an entire business emphasized on operations, R&D, training, clinical and regulatory, quality assurance, and strategic planning
Energetic and balanced person with a drive for results, who feels accountable, has a great attitude, and is a team-player; self-starter with high degree of initiative, urgency, and follow through
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

Nice To Haves

Experience in orthopedics is highly desired, spine experience also a plus

Responsibilities

Reports to the Professional Education Program Manager
Provide leadership to ensure that the goals of the Professional Education department are achieved
Has joint ownership and responsibility for all logistical aspects of our professional education programs
Support fundamental change as to how the medical community views lower back pain and SI-Joint related issues and help position the company as the knowledge leader
Work as a team member to ensure the goals of the department are met in a compliant and consistent manner
The employee must at all times act and conduct company 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. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations
Responsible for performing all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual
Be responsible for managing the scheduling, coordination and logistical set-up of all HCP training courses
Ensure the appropriate pre-course information is sent out in advance of HCP training courses at the appropriate lead-time sufficient to promote the course
Manage the budget of the courses on a running weekly basis to ensure we are compliant and using our resources appropriately and maintaining Sunshine Act reporting
Appropriately coordinate and manage data of training suppliers and training materials up to date
Manage the inventory of training support materials / handouts for training courses and manage the creation or formatting of these where relevant
Maintain training records, budgets, spreadsheets and files
Procure program approvals nationally
Support and enforce regulatory requirements
Provide general admin assistance and support for the department as needed
Up to 50 pounds of lifting and packing of equipment
In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485 or ISO 14971), the employee has the authority to hold any product or Quality documentation from shipment or further processing. The employee has the responsibility and authority to report any instances to Quality and/or Regulatory and his respective management team
Support the SI-BONE Quality System