Job Description :

Job Title:-Labeling/MDR Project Manager/Site Lead

Remote Work(Y/N):-No

Location:- Somerville, New Jersey (NJ) USA

Job details:-

  • B.S. /M.S. in Engineering or equivalent with 10+years of experience in Life sciences –Medical Devices domain/ projects especially in Product Labeling/ EU MDR activities
  • Strong knowledge in Medical Devices Labeling/Content Management
  • Single point of Contact (SPOC) for labeling and EU MDR activities
  • Coordinate between Buyer stakeholders and Subject Matter Experts (“SME/s”) and Supplier Offshore team.
  • Undergo the primary knowledge transfer of labeling requirements, application(s) and successively train the offshore team.
  • Responsible for tracking and maintaining deliverables
  • Interact with Buyer, understand their requirement & provide Offshore delivery team with client expectations
  • Work closely with outside services such as translation houses, service bureaus, design houses and consultants as needed· 
  • Work closely with project leaders on collaborating and collecting the right inputs
  • Provides leadership and direction, championing departmental or cross-functional Labeling initiatives.
  • Exp. & Knowledge of labeling tools like enLabel, A e Illustrator/other tools
  • Exp. & Knowledge of PLM tools change management

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