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RA Manager

Boston, MA
Position Role/Tile: RA Manager
Location: Boston, MA.

Skills: Medical Device Regulation (2017/745) Medical Device Directive (93/42/EEC), FDA (US CFR), EU MDR, GSPR, IDE, 510(k), PMA
  • Perform regulatory activities for transferring recently CE marked products under Council Directive 93/42/EEC to compliance with MDR 2017/745
  • Support preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as assigned.
  • Provide regulatory support for New Project Development projects as assigned with focus on CE marking and US requirements (510(k))
  • Provide regulatory support for Life Cycle Management project as assigned
  • Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.
  • Perform Regulatory Change assessments as assigned,
  • Perform Labeling and Promotional Material Reviews as assigned.
  • provide regulatory strategic support for EU MDR,
  • Advise with regard to compliance with the GSPR,
  • Prepare and submit Technical Documentation according to the EU MDR to the notified body.
EU MDR Technical Documentation application

Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (833)247-8800 Fax: (510)-740-3677

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