To apply, send an email with a subject of JOB CODE D-019 to HR@ Historx.com.  Attach a CV to the email and use the body of the email to convey the additional information that you might have included in a cover letter. Do not include a separate cover letter.  HistoRx, Inc. is an Equal Opportunity Employer.

This position will report to a Vice President. This position will involve the following.

Regulatory Affairs:

• Primary company representative to WW regulatory bodies

• Responsible for all WW Regulatory submissions. These submissions include Investigational Device Exemptions (IDE) Pre-Market Approval (PMA), 510K, Design Dossier, Technical Files, Shonin.
• Primary responsibility for regulatory compliance.
  

Clinical Affairs:

• Supervise or write all clinical protocols.

• Interface with principal investigators.
• Supervise and manage all clinical activities.
• Manage clinical research organizations.
• Open up study sites. Close out study sites.
• Conduct clinical site training on procedure and clinical protocol.
• Insure all clinical products are tracked and traceability is maintained.
  

Quality:

• Coordinate and Manage the Design Controls systems.

• Coordinate and Manage the Production and process controls system including Final product release.
• Responsible for overseeing the creation and maintenance of Quality Systems that are compliant with FDA GMP (21CFR820), and ISO 13485.
• Oversee the coordination, management and maintenance of the customer complaint, corrective action, calibration, environmental controls systems, quality control testing procedures.
• Quality Management representative
  

General Key Accountabilities:

• Manage all personnel assigned to RA, Clinical QA, and QC.

• Keep Leadership team informed of all RA, Clinical QA, QC Issues.
• Perform all regulatory agency interactions.
• Lead the management review process.
• Ensure that the documentation and change control process for the diagnostic is functioning and that all changes are approved by the appropriate personnel.
  

Ph.D. preferred in physical or biological science with 10+-15 years industry experience. Excellent written and verbal communication/presentation skills are essential. The incumbent must possess a proven track record of leadership and establishing strong relationships with others at all levels. Effective collaboration and influence skills are required.