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Position Information

 
Company: Teleflex, Inc.
Location: Mansfield, MA 02048
Job Status/Type: Full Time
Employee
Job Category: Quality Assurance/Safety
Occupations: placeholder text
Industry: Production Quality Assurance
Software Quality Assurance
Work Experience: 2+ to 5 Years
Career Level: Experienced (Non-Manager)
Education Level: High School or equivalent

Regulatory Affairs Labeling Specialist

 

Teleflex, Inc. (NYSE: TFX), with $2.5 billion in revenues and operations in 27 countries, manufactures specialty engineered products for the medical, automotive, marine, industrial and aerospace industries.  With a core competency in OEM manufacturing, we are experts in the markets we service, partnering with our customers to deliver real-world solutions that are practical, cost-effective and reliable.

 

Teleflex Medical specializes in the design, manufacturing and distribution of high quality engineered surgical instruments, medical devices, and healthcare supplies for customers around the world. Teleflex Medical has extensive expertise in cardiovascular, plastic, orthopedic, spinal, urology, gynecology, ENT, and general surgery specialties.

 

The OEM group brings this expertise to our customers through two focused OEM entities. The OEM Specialties business is comprised of TFX Medical, the leading supplier of custom plastic extrusions, braid reinforced tubing, catheter and guide wire fabrication, and Deknatel, the leading supplier of custom sutures and medical fibers.  The OEM Orthopedics business is comprised of Beere and KMedic, the leading suppliers of orthopedic and spinal surgical instruments.  The OEM business is experiencing rapid growth and is seeking a high caliber individual to develop and implement a new discipline within the organization.

 

POSITION SUMMARY

Provide OEM label design and maintenance support to all OEM managed facilities. Work with OEM QA to determine priority.

 

MUST HAVE MEDICAL DEVICE LABELING EXPERIENCE.

 

 

PRIMARY RESPONSIBILITIES   

·         Develop and maintain regulatory compliant label content databases to manage label design, approval and printing of label content across the entire OEM organization.

·         Develop and maintain a back up security systems to assure the security of label data bases, templates hardware and software across the entire OEM organization.

·         Maintain label printing software and hardware

·         Coordinate and control all label design and approval projects across the entire OEM organization.

      Work collaboratively with OEM Quality, Product Development Engineering, Sales, Marketing, Regulatory and external customers to develop label templates that are capable of interacting with label content data bases to produce regulatory compliant label copy.

      Work with OEM Quality, Product Development Engineering, Sales, Marketing, Regulatory and external customers to design OEM label formats for new product development projects using the current approved label design and templates data base.

      Generate CAD drawings of label templates and IFU copy.

      Work with OEM Quality, Product Development Engineering, Customer Care, Sales, Marketing, Regulatory and external customers to make changes to existing OEM label designs using the current approved label design data bases.

·         As directed by OEM QA, liaise between plant personnel and external customers to support changes and to assure all changes are appropriately compliant documented and controlled.

·         Assure that the label content review and approval process is comprehensive and consistently executed across all internal & external relevant functions within the OEM organization.

      Prepare label approval paperwork

      Develop, obtain approval and release label drawings

·         Work with translation, print vendors to coordinate required services and purchases as required per label design and database management projects.

·         Work with hardware and software vendors as required to maintain label system upgrades and integrity

·         Provide support to process improvement projects as assigned by OEM QA.

 

POSITION REQUIREMENTS

·         High School diploma or equivalent is required.

·         An Associates Degree in a Technical field is desired.

·         Three or more years of relevant R&D or medical device experience

·         Knowledge of the following software programs: 

      Adobe Acrobat 5.0, Illustrator, and Photoshop

      Corel

      Other Applicable graphics software

      Access

      AutoCAD 2002 or later

·         Desktop publishing experience with a program such as Quark/In-Design

·         Technical writing

·         Project Management/Organization/Planning

·         Oral and Written Communication

·         Professionalism

 

SKILLS / KNOWLEDGE

·         Ability to communicate effectively with a broad spectrum of people having varying backgrounds, education, and experience.

·         Ability to write clear and effective user instructions.

·         Proficient with Label Max, Bartender and or various labeling software packages.

·         High degree of initiative.

·         Ability to easily interact with customers.

·         Works well in team environment.

 

Please apply by submitting your resume in MS Word format via email to Human Resources, mmjobs@teleflexmedical.com

 

 
About Teleflex

Teleflex is a diversified company with a significant presence in medical technology and niche businesses serving aerospace and commercial markets, providing innovative solutions for customers around the world. Teleflex employs approximately 12,600 people worldwide who focus on providing innovative solutions for customers. Additional information about Teleflex can be obtained from the company's website at www.teleflex.com.

 

Teleflex is an Equal Opportunity Employer D/M/F/V