Technical Writer, Quality Compliance

Integra LifeSciences•Columbia, MD

1d•$94,300 - $129,950•Hybrid

About The Position

The Technical Writer, Quality Compliance is a key member of the Enterprise Compliance Master Plan (ECMP) Team with responsibility to support the Workstream (WS) Leaders by drafting future-state procedural documentation based on the outputs from the applicable ECMP phases, events and regulatory requirements; gathering and reviewing site-level procedural documentation; supporting in-person ECMP and WS-centric events; completing any necessary ECMP forms to capture outputs and outcomes for applicable ECMP phases and meetings; coordinating and routing ECMP related and ECMP WS Output documentation for approval; and reviewing and verifying accuracy and completeness of documents.

Requirements

Bachelor's degree is required
8+ years of experience in technical writing is required, or equivalent, i.e. Master’s degree with 5+ years of experience
Experience in medical device, pharmaceutical and / or biotechnology industries is required
Experience in working within compliance frameworks such as FDA, ISO 13485, and EU MDR is required
Advanced technical writing, presentation, bibliographic research and editorial skills are required
Strong ability to interpret and disseminate relevant product information is required
Strong organizational skills, attention to detail and proofreading skills are required
Demonstrated project management skills are required
The ability to produce procedures, reports and documents independently and evaluate the writing of others is required
The ability to rapidly develop expertise in the company's internal document management system is required
Experience with Electronic Documentation Management Systems and Electronic Approval Systems is required
Being comfortable leading teams and educating team members as needed during process of document development is required

Nice To Haves

Ability to travel up to 40% if needed based on ECMP Workstream needs

Responsibilities

Drafting future-state procedural documentation based on the outputs from the applicable ECMP phases, events and regulatory requirements
Gathering and reviewing site-level procedural documentation
Supporting in-person ECMP and WS-centric events
Completing any necessary ECMP forms to capture outputs and outcomes for applicable ECMP phases and meetings
Reviewing and verifying accuracy and completeness of documents
Coordinating and routing ECMP related and ECMP WS Output documentation for approval
Other duties as assigned