Associate Director of Marketing

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 / Responsibilities
• Develop 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 Policy
• Maintain 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 SOPs
• Develop 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 applicable

• Adhere to Xtant Medical Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and safety protocols
• Complete annual SOP review and OSHA safety training as applicable
• Lead 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 planning
• Build multigenerational product plans with voice of customer inputs form sales and surgeons
• Analyze the performance of new products by collecting data for key metrics and reporting out the performance
• Direct 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 requested
• Directs day-to-day progress of assigned product lines, reviews forecast for product requirements, and develops plans to be ahead of market needs
• Collaborate with Operations, Accounting, and Sales to most effectively manage inventory based on current and projected sales volumes as needed
• Responsible 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 competitors
• Effectively communicate updates on products, the market, and competitive activities with Sales, Customer Service, National Accounts, R&D
• Provide 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 lines
• Develop and launch new products and gather post-market feedback by serving as the interface between surgeons, end users, R&D, and QA / QC
• Serve 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 fashion
• Represent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employees
• Perform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures
• Responsible 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 practice

Adhere 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) Standards

Develop 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 applicable

• Financial Responsibilities
• Submit timely expense reports and abide by the Expense Reimbursement Policy
• Training
• Participate in training plans and programs and complete in a timely manner within set deadlines
• Complete required training prior to attempting to perform a task
• Maintain required training documentation
• Management
• This position may supervise others
• Document Control and Record Control
• Assist in the completion and retention of documentation pertaining to all SOPs as required
• Legibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as required
• Maintain information in physical and electronic files as required
• Train on and demonstrate proficiency in Xtant Medical’s document control system
• Other duties as assigned
• Performance of Duties
• Complete required training, including initial orientation and environmental health and safety training, prior to performing tasks.

Keep training up to date

• Perform all duties according to established procedures and follow appropriate safety precautions and measures
• Conduct himself / herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end users
• Must maintain confidentiality of donor and recipient information according to HIPAA

D. Job Requirements

• Education / Credentials Experience & Training
• Bachelor’s Degree from an accredited college or university is required
• MBA highly preferred
• Five (5) to seven (7) years’ prior experience in spine medical device marketing is required
• Five (5) to seven (7) years’ spinal hardware or biologic product knowledge is required
• Strong technical hands-on knowledge of Xtant products is required
• Technical Requirements / Skills
• General knowledge of ISO 13485 and FDA Quality System Regulation guidelines required, advanced knowledge preferred
• High level of proficiency in Microsoft Office Suite of software applications
• Ability to react quickly and adapt to changes in priorities, circumstances, and direction
• Must be able to reason independently and work with minimum supervision
• Proven ability to read, write, review, and complete contract forms
• Demonstrated ability to communicate effectively both orally and in writing
• Excellent project management skills required
• Must possess excellent organizational skills and strong attention to detail

3. 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

• This position is offered on site in Belgrade, MT or Remote (US)
• 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.

If you think you are the right match for the following opportunity, apply after reading the complete description.

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