Medical Writer Jobs

Must to have: MS Office, Adobe acrobat/reader

Adds Value-Global Vision

Good To Have- EU MDR Knowledge

· Minimum of 2 years experience in medical technology quality/regulatory field, proofreading, technical editing or related field.

• Review medical device labeling redlines and regulatory submission label samples against labeling development input documentation, MDR regulations checklist, and other internal or external requirements.

• Conduct comprehensive quality review of multilingual labeling content to identify lack of consistency or irregularities in content

• Acquire and utilize product knowledge by working with project leads and labeling designers, and by referring to the product, the technical specifications and engineering documentation, and medical device standards and regulation.

• Review and approve labeling in Medtronic’s quality system.

• Comply with assigned and scheduled training requirements

Project Support

• Interface with the Cardiac Surgery business unit leads to determine work needs and priorities

• Follow schedules and reporting for proofreading/editing project status

• Collaborate and communicate with team members to ensure timely completion of assigned projects

• Promote and implement good documentation practices

• Support / monitor change order activity and reporting

• Ability to collaborate and work harmoniously in a team environment