MDR Technical Editor

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

Job Description:

Execute technical editorial standards and related tasks

• Review medical device labeling redlines and regulatory submission label samples and newly created labeling input doc against source docs , MDR regulations checklist, and other internal or external requirements.
• Conduct comprehensive quality review of labeling content to identify lack of consistency or irregularities in content
• Acquire and utilize product knowledge by working with project team and referring to the technical specifications and engineering documentation and medical device standards and regulations
• Review and approve labeling change orders 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 daily 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 within the team

Required Skillset(s) :

• Ability to handle multiple projects on an ongoing basis
• Exceptional attention to detail
• Ability to work independently, prioritize and meet deadlines
• Ability to edit the work of others and provide feedback in a clear, effective, and constructive manner
• Working knowledge and experience in Microsoft Office tools and Adobe Acrobat PDF software

Preferred Skillset(s):

• Experience working in quality systems (e.g., Agile PLM)
• Experience with Text Compare software
• Experience in proofreading/editing labeling content for the medical device industry or regulated environment
• Knowledge of European (MDR, IVDR) and United States medical device regulations and understanding of regulatory requirements
• Knowledge of international standards (e.g., ISO 15223, ISO 7000)
• Knowledge of medical terminology
• Experience creating and reviewing technical specifications

Tata Elxsi offers a comprehensive compensation and benefits package. Tata Elxsi is an affirmative action-equal opportunity employer.

Tata Elxsi complies with all applicable federal, state and local laws regarding recruitment and hiring.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, citizenship status, disability, protected veteran status, or any other category protected by applicable federal, state or local laws.

Tata Elxsi does not currently require partners or employees to be fully vaccinated or test negative for COVID-19 in order to go to Tata Elxsi offices, client sites or Tata Elxsi events, except when mandated by federal, state or local law.

In some circumstances, clients also may require proof of vaccination or testing (e.g., to go to the client site).

What are our perks for Full time employee?

We provide unique options to fit your unique lives!. Our menu of flexible options includes, but is not limited to:

• Excellent healthcare options: Medical, vision, prescription & dental
• Family Focus & Balance: medical, commuters & Dependant FSA, Competitive PTO, Sick Time, and Employee Assistance Program
• Financial Security: Competitive 401(k) match with Safe Harbor Plan
• Employee Recognition Programs
• Perks AT works: Our exclusive one-stop online discount marketplace