Labeling & Document Control Specialist EU MDR
(European Union) (Medical Device Regulation)
Location: Mansfield, MA - Must work on site
Rate: $30+ DOE
Nesco Resource has an opportunity with a global medical device company for a full-time Labeling & Document Control Specialist to create label design, approval, and printing of label content for the performance fibers business to support EU MDR requirements. You will document change analysis for the processing and releasing of all document and labeling changes associated with MDR in client's software system. In this position you will assign trainings to new documents as required.
-Develop and maintain Regulatory compliant labeling per EU MDR and internal procedure requirements.
-Work with appropriate cross functional departments and external customers to design OEM label formats for new product development projects using the current approved standards; revise existing OEM (manufacturing) label designs using the current approved label design standards; and develop label templates that are capable of interacting with label content data bases to produce regulatory compliant label copy.
-Liase between plant personnel and external customers to implement label changes and to ensure all changes are appropriately documented and controlled.
-Ensure that the label content review and approval process is comprehensive and consistently executed across all internal and external relevant functions within the OEM organization.
-Prepare labeling Document Change Order (DCO) packages, route for internal and external approval and oversee package until closure.
-Work with engineering to develop and obtain approval and release of label drawings.
-Work with all document owners to ensure each document change order package (DCO) is correctly structured per the client's document change process.
-Work with the Quality System and Documentation Specialist for the timely assignment of training requirements for all new document releases.
MUST HAVEs / PREFERRED
-Document Control Change Process knowledge
-Creation of IFU's/labeling,
-Indesign knowledge preferred
-MDR experience & medical device knowledge would be helpful
-Minimum of a High School diploma or GED is required.
-Associates Degree in a Technical or Graphics field is desired and a huge plus!
-Minimum of three years of relevant experience, working with labeling & the document change/training processes.
-Experience in the medical device industry, Design and Development Process, and EU MDR preferred
Specialized Skills / Other Requirements
Strong computer skills including Microsoft Office, Word, Excel, Access, Outlook
Strong working knowledge of Adobe CS Suite (InDesign, Illustrator, Acrobat), BarTender, or similar label design software required.
Strong project management, organization and planning skills
Ability to write clear and effective user instructions
Ability to communicate effectively with a broad spectrum of people
Ability to prioritize projects and adapt to shifting priorities.
Fluent in spoken and written English
Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
- Adobe Acrobat
- Adobe Creative Suite
- Adobe Illustrator
- Adobe In Design