Medical Device Technical Writer

Primary Talent Partners has a new contract opening for a Medical Device Technical Writer with our medical device client in North Haven, CT. This is a 12-month contract with a potential for extension.

Pay: $45.00 - $55.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.


Description:
Top 3 skills sets required:

1. Strong collaboration and verbal/written communication skills.
2. Experience with various authoring tools (eg, InDesign, Framemaker, XML tools).
3. Experience in complex regulatory environments and robust quality processes.
   

 
3 Main Responsibilities/day to day activities required for this role:

1. Update product manuals to align with cross-functional feedback, standards compliance, and other inputs in alignment with Tech Comm and business quality processes.
2. Support approvals in PLM tools, facilitate translations requests, and support launch activities (electronic and hardcopy distribution activities, such as metadata information and print proofs).
3. Participate in project and team meetings, and collaborate with teams to create, analyze and finalize product manuals from planning through launch.

 
Target years of experience: 

• 5 -10  years
  
  

Responsibilities may include the following and other duties may be assigned:

• Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision.
• Simultaneously manage up to two labeling updates and one small, new-product-introduction project that involves multiple labeling pieces.
• Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
• Conducts interviews with various users and technical staff to gather data for documentation.
• Recommends formats responsive to technical and customer requirements.
• Assist in providing documentation for CAPAs, and departmental and business-unit audits.
• Contribute to time and cost estimates for labeling deliverables for project teams.
• Develop illustrations in cooperation with professional illustrators.
• Participate on department and business-unit initiatives.
• Oversee Engineering Change Order process for labeling.
• Coordinate translations and track the status of translations.
• Complete labeling proofs, develop documentation for regulatory submissions, and carry out other tasks as assigned
  
  

Qualifications:

• Requires a University Degree 
• 5-10 years of relevant experience technical writing for medical devices (labeling experience a plus, but not required)
• Experience with various authoring tools (eg, InDesign, Framemaker, XML tools).
• Experience in complex regulatory environments and robust quality processes.
• Strong collaboration and verbal/written communication skills.
  
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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