Senior Manager of Regulatory Affairs

22 May, 2023


Senior Manager of Regulatory Affairs

Xtant Medical
Belgrade, MT
Salary Range:$105,000.00 To 110,000.00 Annually

Status: Full Time, Exempt

Reports To: Vice President of Quality and Regulatory Affairs

A.        Purpose and Scope of Position

This position will manage and supervise quality, and regulatory compliance in the QA department and other applicable departments as required.

This position ensures that Xtant complies with and meets the standards of the FDA, AATB, ISO 13485, MDD, CMDR and other regulatory agencies as necessary.

B.        Organizational Relationship 

This position reports directly to the Vice President of Quality and Regulatory Affairs and supervises others.  This position interacts with employees in the Department and may interact with other Department Managers, Supervisors, and employees.

C.        Duties and Responsibilities

  1. Specific Job Duties/Responsibilities
    • Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA); American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; Medical Device Single Audit Program (MDSAP); and other regulatory jurisdictions, as applicable, 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
    • Complete annual SOP review and OSHA safety training as applicable
    • 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 SOPs
    • Manage regulatory personnel to help ensure continued regulatory compliance to reduce regulatory risk to Xtant. Complete performance reviews and performance correction notices if applicable
    • Represent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employees
    • Ensure that Xtant properly addresses all state, federal and foreign regulatory requirements
    • Maintain required establishment, tissue and medical device licenses and registrations
    • Maintain international registration projects
    • Lead coordination of product recalls/advisory notices
    • Develop regulatory strategies for new and modified medical devices
    • Prepare and submit Pre-submissions, and 510(k)s according to FDA guidelines
    • Prepare and submit inquiries to the Tissue Reference Group (TRG)
    • Management of Premarket Approvals (PMA)
    • Create and maintain Summary of Technical Documentation (STED) for assigned products including maintenance of risk management files, product verification and validation documentation, post-market surveillance, with cross-functional leads
    • Create and maintain Declaration of Conformity files according to applicable jurisdictional requirements
    • Proactively monitor relevant regulatory bodies both domestic and foreign to identify changes in legislation/regulations
    • Review change orders (e.g., quality system documents such as SOPs and Wis, DMRs and labels). Assess changes and their impact on PMA, 510(k) and international registrations
    • Review device labeling and advertising materials for compliance with regulatory submissions and applicable regulations
    • Participate in and help lead successful audits (regulatory agencies, customers, etc.)
    • Participate in supplier qualification activities as requested, including but not limited to supplier audits
    • Perform internal audits as requested
    • Oversee complaint system, including investigations, trending, response to complainant and closure of complaints
    • Investigate Adverse Outcomes and report to regulatory bodies as required
    • Perform CAPA investigations as requested
    • Ensure that the company’s products comply with applicable regulations
    • Perform sterilization, cleaning, and shipping validations as requested
  2. Financial Responsibilities
    • Submit timely expense reports and abide by the Expense Reimbursement Policy
    • Maintain strict confidentiality of all company, customer, and donor information.
  3. 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
    • Train and supervise the training of others in Department activities. May review and maintain employee training records
  4. Management
    • This position supervises others
    • Work with and support the activities of the Vice President of Quality and Regulatory Affairs
    • Help direct the activities of Department employees to accomplish quality and company objectives
    • Ensure the regulatory team delivers the highest standard of department, cross-departmental, and cross-foundation teamwork
    • Develop department goals that are fully aligned with the company goals
    • Assist in the hiring of skilled, responsible, and ethical individuals for the Department
    • Participate in performance reviews and issue performance correction notices as necessary
  5. 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
  6. Other duties as assigned
  7. 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
    • Always maintain a clean and safe working environment
    • Must maintain confidentiality of donor and recipient information according to HIPAA

D.        Job Requirements

  1. Education/Credentials Experience & Training
  • Bachelor’s or Master’s degree from an accredited college or university relating to the specific department
  • Minimum of eight (8) years’ experience that is directly related to the duties and responsibilities specified
  • Certified Tissue Bank Specialist (CTBS) certification is preferred or must be willing to obtain certification if applicable per department specific requirements
  • Advanced knowledge and experience in biologics manufacturing or other relevant cleanroom/aseptic environments
  • Knowledge of the relevant regulations in the medical technology environment (MDD/MDR, FDA)
  • Audit experience according to ISO 13485, 21 CFR 820, MDSAP, with a certified additional qualification as an auditor is preferred
  1. Technical Requirements/Skills
  • Advanced knowledge of FDA, ISO, and AATB requirements
  • Successful preparation and submission of 510(k)s and international documents or registrations
  • Ability to write, review, and edit technical reports and SOPs
  • Experience in regulatory standards, regulatory inspection hosting, GLP, GMP and GDP
  • Must possess excellent organizational skills and strong attention to detail
  • Proficient computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
  • Advanced ability to communicate effectively both orally and in writing and the ability to present effectively to small and large groups
  • Ability to assist in the development and presentation of educational programs and/or workshops
  • Strong leadership and interpersonal skills and the ability to effectively communicate with a wide range of individuals in a diverse community
  • Ability to investigate and analyze information and to draw conclusions
  • Ability to travel as company representative

3.      Managerial Experience

  • A minimum of four (4) years’ experience in a supervisory capacity is required

4.      Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications

  • Must be able to reason independently and work with minimal guidance
  • Ability to interpret data and make sound judgments based on those interpretations
  • Must deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poise
  • Must be able to adapt to quickly changing priorities and schedules
  • Ability to maintain good working relationships with all co-workers and the general public and use good judgment in recognizing scope and authority
  • Must possess mobility to work in a standard office setting and to use standard office equipment and to attend meetings at various sites within and away from the office

5.         Working Conditions

  • Working conditions are normal for an office environment. Standard office hours are Monday – Friday; 8:00 am – 5:00 pm
  • Work will require occasional weekend/evening work and travel
  • Work may require long periods of sitting, standing, and working at a computer
  • 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.
  • Will require experience or training in the routine handling of chemicals and biohazards
  • 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
  • Must be able to physically handle objects up to 20 lbs.

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.

**  This position does not offer future or current H-1B Visa Sponsorship ** 

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.

Learn more here

Job posted: 2023-05-22