Business Process Owner – Bpo – Labeling

Business Process Owner – Bpo – Labeling

Requirements

• Minimum of a BS/MS degree in life science, engineering or other relevant discipline
• At least 8 years of experience in a Class I/II/III medical device with specific experience in Labeling
• Proven experience with interpretation and application of FDA CFR 820.30, FDA CFR 820.801, ISO 13485, EUMDR, UDI, and ISO 15223-1, and other regulation related to labeling
• Demonstrated experience establishing global Quality strategy & oversight, QMS etc., at business/manufacturing site level in a global company
• Strong background in labeling in relation to product design and development
• Strong understanding of design control requirements and regulation
• Proven ability as a change agent to drive improvements across a large organization
• Strong technical writing experience required
• Ability to develop creative approaches and solutions necessary to resolve complex problems
• Strong communicator capable of interfacing at senior levels
• Understanding of the application of quality systems to the medical device industry
• Ability to work effectively and influence leading decision makers across diverse areas of BD and manage complex structures
• Proven ability to work globally; ability to lead a global team and lead across cultures and regions
• Articulate with ability to influence others and significantly promote and/or negotiate in situations that involve recognizing and responding to underlying concerns where others need to be persuaded to accept compromised solutions

Responsibilities

• Owns and ensures the development and maintenance of the labeling process, including that the applicable procedures, work instructions, templates, and tools are effectively implemented within the MMS business unit
• Works in conjunction with the Product Development Process leadership, Global labeling policy owners, and critical stakeholders to maintain a comprehensive labeling program across the MMS business unit
• Produces and delivers related training programs
• Participates on a team bringing core product development and post-market business processes to the MMS business
• Coordinates, organizes, and reports on project activities
• Serves as subject matter authority on labeling-related topics
• Leads continuous process improvements and partners with stakeholders and Subject Matter Experts on key initiatives
• Ensures consistent application of labeling activities across all elements of the Quality System (e.g. CAPA, Field Actions, etc)
• Monitors industry surveillance audit outcomes and takes necessary actions to align process to incorporate learnings
• Monitors internal and external audit observations within BD, identifies the appropriate cause and implements fixes for labeling
• Works with standards committee to monitor for external regulatory changes and determines need for changes to policy, procedure and practices based on regulatory changes and implements where appropriate
• Supports regulatory inspections and audits
• Participates in a collaborative community (cross site/cross functional network of SMEs) which will support and drive change

Preferred Qualifications

• Experience with both hardware and software applications is preferrable.