By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers’ success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
- You will adhere to Integer Core Beliefs and Values all safety, environmental, security and quality
- requirements including, but not limited to: Quality Management Systems ( Safety, Environmental and
- Security Management Systems, U.S. Food and Drug Administration ( regulations, company policies
- and operating procedures, and other regulatory requirements.
- You will contribute to global clinical strategies to support clinical evidence requirements for product
- submissions and post submission activities.
- You will represent the Clinical Affairs function on product development teams.
- You will work directly with representatives from cross functional areas in possibly multiple geographical locations
- You will ensure clinical data integrity in support of the quality and regulatory functional group needs. This will include the use of software to appraise, analyse and evaluate clinical and state of the art data to generate appropriate clinical evidence to support Integer Technologies
- You will generate interim and final reports.
- You will support Integer initiatives with the development and upkeep of market specific clinical training.
- You will support investigator conferences to review findings and advise on direction.
- You will interface with, and assure training of investigators/physicians, centre staff and Integer Clinical
- Affairs staff.
- You will support adequate monitoring is conducted on all clinical trials.
- You will provide a clinical perspective and approval on field complaint investigations
- You will work with regulatory bodies for the purpose of facilitating regulatory approvals and queries.
- You will s upport the development of Integer technology including objectives, strategy, scope, budget, and schedule from proof of concept research, development through post market commercial phases
- You will perform other functions as required.
How you will be measured:
- The specific measures listed below may be subject to change and are not intended to be an all inclusive list
- Safety is our highest priority; you will be an