Medical Device Labeling Specialist
Mastech Marlborough, MA
- Posted: over a month ago
Mastech Digital provides digital and mainstream technology staff as well as Digital Transformation Services for all American Corporations. We are currently seeking a Medical Device Labeling Specialist for our client in the Medical Technology domain. We value our professionals, providing comprehensive benefits and the opportunity for growth. This is a Contract position and the client is looking for someone to start immediately.
Duration: 6+ Months Contract
Location: Marlborough, MA
Role: Medical Device Labeling Specialist
Primary Skills: Technical Support
Role Description: The Medical Device Labeling Specialistmust have at least 3 years of experience.
- Research, create, and revise medical device product labels and IFUs.
- Updates for MDR changes, notified body, EU authorization rep., etc.
- Update cartons, labels, and IFUs to meet current standards
- Change management documentation. Reports on all labeling related activities.
- Pro-actively solicits training from in-house technical experts to help with design and development of product labels and IFUs.
- Ensures design and production methods and processes are executed in a manner which supports the - Quality Policy as well as all ISO Quality System procedures and guidelines.
- 3-5 years related experience in Medical Device labeling.
- Proficient with graphic design programs and creative standards and specifications.
- Demonstrated proficiency in use of various desktop publishing applications such as Adobe Acrobat, Photoshop, Illustrator, InDesign as well as Microsoft Office products.
- Comprehension of UDI and GUDID requirements.
- Strong understanding of Labeling control systems and regulations, MRP and engineering release standards and processes.
- Strong computer literacy and file management abilities to maintain a digital archive library.
Education: Bachelor’s degree in Computer Science, Electrical/Electronic Engineering, Information Technology or another related field or Equivalent
Experience: Minimum 3years
Relocation: This position will not cover relocation expenses
Local Preferred: Yes
Note: Must be able to work on a W2 basis
Recruiter Name: Harshit Agarwal
Recruiter Phone: 412-436-0333 (Ext: 2196)
Equal Employment Opportunity
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