Regulatory Affairs Specialist

Status: Full Time, Exempt

Reports To: Vice President, Quality Assurance and Regulatory Affairs

A. Purpose and Scope of Position

This position will contribute to the maintenance and management of an effective Quality Management System (QMS) within the QA/RA department. This position ensures that Xtant complies with and meets the regulatory requirements and industry standards of FDA, AATB, ISO, and other regulatory agencies as applicable.

B. Organizational Relationship

This position reports directly to the Vice President of Quality Assurance and Regulatory Affairs. This position is responsible for communicating effectively with individuals across all departments, as well as with external contacts such as customers. This position may provide additional support to other supervisors, managers, or departments as requested and provide guidance and advice to colleagues.

C. Duties and Responsibilities

1. 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
   • Represent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employees
   • Participate in activities required for regulatory strategy development, including research of standards and US FDA guidance documents, and communication of the information pertaining to the appropriate regulatory pathway for new or modified products.
   • Support and complete post market activities, including post market surveillance, regulatory reporting, and recall and correction management
   • Maintain required establishment, tissue and medical device licenses and registrations
   • Develop and prepare product registration submissions for select jurisdictions
   • Identify potential regulatory approval risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project.
   • Apply for, maintain, and distribute Certificates to Foreign Government (CFG) as necessary
   • Maintain records in the Global Unique Device Identification Database (GUDID)
   • Manage Complaint System. Perform Complaint related activities, such as regulatory reporting determination, investigations, root cause analysis, justifications, corrections/corrective actions, complainant response. Responsible for maintaining Quality Objectives as they relate to the Complaint System.
   • Prepare regulatory submissions in accordance with applicable regulatory requirements.
   • Complete Nonconformance and/or CAPA related activities such as, regulatory reporting determination, risk assessment, investigation, root cause analysis, justifications as requested
   • Perform Internal Audits and/or prepare audit responses as requested
   • Participate in regulatory agency audits and/or prepare audit responses as requested
   • Perform trend analyses using statistical techniques and/or validated excel software
   • May perform Device History Record reviews
   • Assist in the development, implementation, and tracking of Department-specific training. May assist in the maintenance of training records
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
4. Management
   • This position does not supervise others
5. Document Control and Record Control
   • May assist in the development and maintenance of Document Control and Record Control systems that meet FDA, AATB, and ISO standards and regulations
   • Assist in the completion and retention of documentation pertaining to SOPs. Understand the importance of completing and maintaining documents and records without any errors
   • Legibly and accurately complete all documentation associated with assigned duties in accordance with current GDP and review the information of others as required
   • Write and revise a variety of technical documents including SOPs (Standard Operating Procedures), quality standards and specifications, training documents, and inspection and testing protocols as needed and assigned
   • Participate in the completion of Device History Records (DHR) or Donor Processing Records as applicable
   • Participate in changes to documents and to products and processes
   • Maintain information in physical and electronic files as required
   • Respond to and prioritize requests for Document Numbers, Part Numbers, etc. and maintain adequate records, updating In-Use Logs as necessary
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 and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant SOPs
   • 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 is required
• Three (3) – five (5) years’ experience in Quality Assurance and/or Regulatory Affairs for medical device or related industry
• Must have or be willing to obtain and maintain CTBS certification
• Must be willing to obtain RAC certification
• Interpret complex data and make sound judgments based on those interpretations

1. Technical Requirements/Skills

• Understanding knowledge of FDA, ISO, AATB and foreign regulatory requirements as applicable
• Basic knowledge of risk management principles and ISO 14971
• Strong interpersonal, organizational, problem-solving, and analytical skills with strong attention to detail
• Demonstrated strong writing and communication skills
• Ability to manage competing priorities and versatility and willingness to work with changing priorities
• Ability to train and cross-train others
• Proficient computer skills required such as knowledge of MS Word, Excel, Power Point, Outlook, and other software as necessary
• Ability to investigate and analyze information and to draw conclusions
• Some experience with records maintenance and document control required

3. Managerial Experience

• N/A

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
• Must be able to communicate with suppliers and other regulatory agencies as necessary
• 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

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 current or future 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.