Director of Regulatory Affairs and Quality Assurance; RA​/QA)

Position Summary

As the Director of Regulatory Affairs and Quality Assurance (RA/QA), this position is responsible for ensuring global leadership in RxFunction by influencing the creation of,and ensuring compliance with, the global regulatory requirements for the company's emerging medical device initiatives. This position will interact with the FDA, Notified Bodies, and other regulatory authorities as needed to develop the regulatory strategies and to manage all aspects of their execution regarding RxFunction products.

This position is responsible for ensuring the overall effectiveness of the regulatory compliance program and the quality management system (QMS) throughout the organization, including its ongoing conformance with quality certification standards. It reports to the VP of Technology and works with all critical functions of the organization.

Responsibilities include, but are not limited to, the following:

Directs and oversees theRA/QA department.

• Ensureseffectivestaffing,wages,andprofessionaldevelopment.
• Provides leadership,supervision,anddevelopmentopportunitiestodirectreports.
• Verifiesperformanceofdirectreportsandmakingfairperformancedecisions.
• Preparestheannualdepartmentbudgetincoordinationwiththe Finance department.
• Develops, in collaboration withkeystakeholders, theglobalregulatorystrategy for RxFunction products and ensures its implementation.
• Identifiesapplicableregulations,standards,andguidancedocuments.
• Ensures compliant, complete, andaccurateregulatory submissions toFDAand international regulatory authorities.
• Ensuresthatallsupportingdocumentationisproperly approvedandmaintained, whether or not a formal submission is required by FDA or another regulatory authority.
• ImplementsandmaintainsaneffectiveQMS,includingallrequired documentation.
• Ensuresproductqualitythroughout newproductdevelopment, designtransferto production, production changes, and post-production activities.
• Makesthefinaldecision onproductqualityholdsand releases.
• Ensuresthatriskmanagement evaluation andmitigationtechniques are applied throughout product realization activities.

Securesmarketapprovalsfor Rx Functionproductsintargetgeographies .

• Develops, in collaboration withkeystakeholders, theglobalregulatorystrategy for RxFunction products and ensures its implementation.
• Identifiesapplicableregulations,standards,andguidancedocuments.
• Ensures compliant, complete, andaccurateregulatory submissions toFDAand international regulatory authorities.
• Ensuresthatallsupportingdocumentationisproperly approvedandmaintained, whether or not a formal submission is required by FDA or another regulatory authority.
• ImplementsandmaintainsaneffectiveQMS,includingallrequired documentation.
• Ensuresproductqualitythroughout newproductdevelopment, designtransferto production, production changes, and post-production activities.
• Makesthefinaldecision onproductqualityholdsand releases.
• Ensuresthatriskmanagement evaluation andmitigationtechniques are applied throughout product realization activities.

Servesasthe Quality Management  Representative.

• EnsuresthatprocessesneededfortheOMSaredocumentedand maintained.
• Reports totheleadership teamontheperformance of theOMSandanyneedfor improvement.
• EnsuresthepromotionofawarenessofOMS,regulatory and customer requirements throughout the organization.
• Prepares andleads Management Review meetings, which includes preparation and distributionofmaterialsregarding theOMSperformance relativetoqualityobjectives.

Chairsthe Cybersecurity Panel,whichreviewsandapprovesallcybersecurity risk assessments, mitigations, and residual risk justifications and escalations.

Maintainsthehighestlevelsofethicsand confidentiality.

Otherdutiesandresponsibilitiesmaychangeorbeassignedatanytimewithorwithout notice.