Status:
Full Time, Exempt
Reports To:
Vice President of Marketing
A. Purpose and Scope of Position
This position is responsible for directing all Cervical and Dynamic Stabilization products and working directly with Sales, Marketing, Operations, and R&D departments to promote Xtant products, lead in the development of new products, provide technical assistance to the sales force and distributors, and gather information on the design, performance, and utilization of Xtant products. This position will ensure Xtant Distributor Agents, Xtant Sales Management, and Xtant Corporate employees have all the tools they need to sell and accurately delivery materials needed for surgery.
B. Organizational Relationship
This position reports to the Vice President of Marketing and is responsible for communicating effectively with other individuals within Research and Development, Operations, Sales, Marketing and International and other departments as needed.
C. Duties and Responsibilities
Specific Job Duties/ResponsibilitiesDevelop and maintain an understanding of the requirements of the applicable standards and regulations including, but not limited to, 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485. Adhere to and promote compliance with the applicable standards and regulations throughout the company Support Xtant Medical’s mission, values, and Quality PolicyMaintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant Medical SOPsDevelop and maintain an understanding of the Xtant Medical products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicableAdhere to Xtant Medical Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and safety protocolsComplete annual SOP review and OSHA safety training as applicableLead market research efforts to develop product growth strategy that includes customer segmentation, development of new products, and increased market penetration for short, medium, and long-term planningBuild multigenerational product plans with voice of customer inputs form sales and surgeonsAnalyze the performance of new products by collecting data for key metrics and reporting out the performanceDirect surgeons through the Annual Needs Assessment process to create Surgeon Advisory Role, Peer to Peer consultation opportunities, Case Studies, Surgeon Testimonials, Voice of Customer, and Surgeon Led Training Webinars in the creation and maintenance of training and in-service materials for product line and conduct product trainings and seminars to internal and external personnel as requestedDirects day-to-day progress of assigned product lines, reviews forecast for product requirements, and develops plans to be ahead of market needsCollaborate with Operations, Accounting, and Sales to most effectively manage inventory based on current and projected sales volumes as neededResponsible for developing marketing materials for new product launches or updates to existing or old literature, advertising ideas, direction, conference support, etc.Produce competitive analysis and materials comparing product with its key competitorsEffectively communicate updates on products, the market, and competitive activities with Sales, Customer Service, National Accounts, R&DProvide technical support to the sales force and travel to assist in meeting sales objectives as needed Conduct on-going research to define market needs (includes interfacing with hospital personnel, surgeons, nurses, and sales representatives, surgical observation, and literature review) to develop and maintain product linesDevelop and launch new products and gather post-market feedback by serving as the interface between surgeons, end users, R&D, and QA/QCServe as a point of communication between R&D, Marketing, Sales, and Operations to make sure new products are effectively introduced to the market in a coordinated fashionRepresent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employeesPerform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measuresResponsible for maintaining all expenses within budget Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; European Medical Device Directives (MDD); and Canadian Medical Device Regulations as applicable and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practiceAdhere to Xtant Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) StandardsDevelop and maintain an understanding of the Xtant products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicableFinancial ResponsibilitiesSubmit timely expense reports and abide by the Expense Reimbursement PolicyTrainingParticipate in training plans and programs and complete in a timely manner within set deadlinesComplete required training prior to attempting to perform a taskMaintain required training documentationManagementThis position may supervise othersDocument Control and Record ControlAssist in the completion and retention of documentation pertaining to all SOPs as requiredLegibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as requiredMaintain information in physical and electronic files as requiredTrain on and demonstrate proficiency in Xtant Medical’s document control systemOther duties as assignedPerformance of DutiesComplete required training, including initial orientation and environmental health and safety training, prior to performing tasks. Keep training up to datePerform all duties according to established procedures and follow appropriate safety precautions and measuresConduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end usersMust maintain confidentiality of donor and recipient information according to HIPAAD. Job Requirements
Education/Credentials Experience & TrainingBachelor’s Degree from an accredited college or university is requiredMBA highly preferredFive (5) to seven (7) years’ prior experience in sales and marketing is requiredFive (5) to seven (7) years’ prior experience in medical device or pharma brand marketing is requiredFive (5) to seven (7) years’ spinal hardware or biologic product knowledge is requiredStrong technical hands-on knowledge of Xtant products is requiredTechnical Requirements/SkillsGeneral knowledge of ISO 13485 and FDA Quality System Regulation guidelines required, advanced knowledge preferredHigh level of proficiency in Microsoft Office Suite of software applicationsAbility to react quickly and adapt to changes in priorities, circumstances, and directionMust be able to reason independently and work with minimum supervisionProven ability to read, write, review, and complete contract formsDemonstrated ability to communicate effectively both orally and in writingExcellent project management skills requiredMust possess excellent organizational skills and strong attention to detail3. Managerial Experience
- Three (3) to five (5) years’ prior management experience required
- Ability to train, cross-train, direct, and mentor others
- Participate in performance reviews and issue performance correction notices as necessary
- Excellent management (project and people) skills
- Ability to delegate responsibility and commensurate authority to the organization, while remaining hands-on with attention to detail
5. Working Conditions
- Standard hours are Monday – Friday; 8:00 am – 5:00 pm
- Work may require occasional weekend and evening work and 4+ hours of standing
- Administrative work may be done out of a home office
- Work will require 25% - 50% travel
- Working conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments.
- Duties may include contact with human tissue, blood, bone, and fluids (Clinical Laboratory, Donor Services, Engineering, Processing, Packaging and Labeling, etc.). Working in PPE such as cleanroom suits, with face shields and masks as necessary.
6. Health and Safety
- Must adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products
- This position will sometimes be required to wear personal protective equipment (PPE), including laboratory coat, scrubs, and gloves, etc.
- May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
- Hepatitis B vaccine is highly recommended and provided to employees who may have contact with human tissue at no cost to the employee. Any employee who declines a Hepatitis B vaccine will be required to sign a waiver
Note:
This Job Description is not designed to include a detailed listing of the activities, duties or responsibilities that may be required of the employee. This job description does not constitute an employment contract, implied or otherwise, and is subject to change by the employer as the needs of the employer and requirements of the job change.Xtant Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
