Associate Director, Regulatory Affairs and Quality Assurance (RA/QA)

Organization: 
XDx
Job Location: 
Brisbane, CA
Benefits: 

The position offers a competitive salary, and equity compensation along with a competitive benefits and 401K package.

Job Description: 

The Associate Director, RA/QA, is responsible for working with all stakeholders to define and implement the company’s regulatory strategy in support of CLIA, ISO, CE-Mark, FDA submission and QSR regulations and to oversee the overall XDx Quality Management System. The Quality Management System must assure compliance with regulations and standards set forth by regulatory and accrediting agencies. A qualified candidate must establish effective partnerships with internal staff to facilitate the timely identification and resolution of compliance / quality matters as well as opportunities for quality process improvement. This person will track / trend data and provide reports to management for evaluation. This position will oversee Design Control for products regulated by the FDA. In addition, the position will oversee the company’s document control function, regulatory submissions, and internal and external audits.

Requirements: 

Responsibilities are as follows, but not necessarily limited to:
• Serves as the management representative for the XDx Quality System
• Serves as (or delegates) the primary interface with regulatory bodies for non-CLIA-related operations
• Establish and manage a Quality Management System
• Drive the development, implementation and monitoring of Quality System processes, including but not limited to Management responsibility, quality audits, personnel, design control, purchasing controls, CAPAs and complaints.
• Build and maintain the Internal Quality Audit system.
o Perform periodic internal audits of the quality management system to ensure compliance to written procedures and regulatory requirements.
o Generate audit / assessment reports/trending analyses, including follow through proposals for resolution
• Conduct supplier assessment audits/surveys; contribute to the definition of requirements for XDx approved supplier lists for materials, equipment and services.
o Generate audit / assessment reports/trending analyses, including follow through proposals for resolution
• Manage CAPA system; coordinate MDR investigations; interact with all key internal customers
• Manage the electronic Document Control system to assure compliance to in-house and/or external specifications and standards such as GMPs and ISO regulations
• Work as a business partner in collaboration with Marketing, Sales and Research and Development to review education materials, training programs and technical documentation provided externally.
• Create, implement and manage a regulatory training program for employees.
• Provide regular RA/QA updates to the XDx CEO
• Provide regular updates to the XDx Executive group and Operations Committee
• Provide a collaborative and team-oriented approach to problem solving.
• Play a leading role in defining the regulatory and quality strategy to support product commercialization.
• Responsible for balancing business needs with emerging and evolving regulatory requirements
• Provide strategic direction and anticipate the impact of emerging regulations on research and development activities, laboratory operations, and commercial operations.
• Responsible for acquisition and generation of documentation for submission to regulatory agencies
• Participates in other tasks as needed

III. Work Environment:
Travel is not a primary aspect of this position although some travel may be requested from time to time. An employee in this position may work in an environment, or visits facilities, in which safety, environmental and health concerns may demand constant attention. Adherence to the Corporate and/or Plant policies, rules, and regulations in these areas is required.
IV. Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands and fingers, handle or feel, and talk or hear. The employee frequently is required to sit, stand and walk. There will be periods of time during the workday where you will be sitting for 3-4 hours in a row. Requires regular use of hands to operate office equipment and type on the keyboard. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

V. Qualifications:
• Bachelor of Science degree in scientific field preferred with 5-7 years of related experience.
• Experience with FDA, CLIA audits and inspections
• Experience working with and/or leading cross functional teams
• Previous FDA regulatory submission experience (e.g., 510(k), PMA)
• Knowledge and understanding of both CLIA and IVD Directive compliance, ISO 13485 and FDA/QSR regulatory requirements pertaining to IVDs a must.
• Experience in a CLIA-regulated laboratory environment desirable.
• Experience with IVD Multivariate Index Assays (IVDMIA) products desirable.
• Computer skills competency including Excel, Word and PowerPoint programs required
• Experience with commercially available document control databases strongly desired.
• People skills a must

Contact Information: 

XDx is an Equal Opportunity Employer. Direct candidates; no recruiters; no calls
To Apply Email CV to jobs@xdx.com; specifying the job title in the subject line of email. Direct candidates only; no recruiters; no calls.

About Our Organization: 

XDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of non-invasive tests for the monitoring of transplant rejection and autoimmune diseases. The company has developed the AlloMap Molecular Expression Testing, an FDA-cleared test, which provides transplant physicians with a tool to aid in the determination of the probability of acute cellular rejection for post-cardiac transplant patient management. AlloMap is marketed in the U.S. and was launched this year in Germany and Switzerland, with additional European countries to follow in the future. Some of the AlloMap technology developed and implemented by XDx in heart transplant patient management may be applicable to other conditions that involve transplant rejection and diseases that affect the immune system. XDx’s non-invasive technology offers the potential to decrease healthcare costs and improve the quality of life for patients with a variety of life-threatening or life-altering immune-mediated diseases.