Label Specialist
4 tygodni temu
Job Description
:The Label Specialist is responsible for compliant and efficient design of new, and update of existing medical device product labels (both manufactured internally and procured from third party supplier base) and their components.
In collaboration with RA makes sure that labels follow international regulations as well as business requirements.
Within new product development projects and product lifecycle management projects or activities, the label specialist orchestrates product label creation and update in collaboration with various functions such as regulatory affairs, product management, IT, and packaging development.
The Label specialist supports the maintenance of process related documentation (procedures, work instructions and templates), handles efficient resolution of the issues, complaints or CAPAs.
Furthermore, he/she supports continuous business process improvement and computerized system validation of underlying applications.
#LI-SM1
Job Requirements:
Critical Knowledge and Qualifications:
Technical degree or a degree in a related field
Knowledge of standards (e.g. ISO 13485, MDR, CFR21, GxP)
Fluent in Business English (spoken and written)
Critical Skills/technical know-how:
Expert knowledge in relevant tools (SAP DMS, MS Office, Label Systems such as Opal, Label Design Software such as NiceLabel) and printing capabilities
Very well organized in keeping track of all activities required for labels creation/update.
Familiar with layout and graphics programs (e.g Adobe Illustrator) and ERP (SAP) for data creation and transition to labels.
Resilient, reliable, detail and service-oriented personality
Is able to lead improvement initiatives or projects within functional area
Document change control
Critical Experience:
5+ years relevant professional experience in the field of labeling (preferably labels creation), quality, RA, or Research and Development, ideally in regulated industry (such as Medical Device).
This role is a remote role based in Portugal, Spain, Italy, France, Germany, Poland, Netherland or Belgium.
Operating Company:
Nobel BiocareEnvista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
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