BRIOHEALTH SOLUTIONS INC
Technical Writer Job at BRIOHEALTH SOLUTIONS INC in Burlington
BRIOHEALTH SOLUTIONS INC, Burlington, MA, US
Job Description
Job Description
Job DescriptionBrioHealth Solutions Inc. is seeking a highly skilled and motivated individual to join our team as a Technical Writer. In this unique and exciting role, you will be responsible for developing technical documentation for the BrioVAD implantable blood pump and related mechanical circulatory support (MCS) technologies. This includes preparing technical documentation to support domestic and international regulatory submissions, instructions for use, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications as necessary to market BrioHealth Solutions products in compliance with applicable global regulations and standards. The role requires a broad understanding of IFU and label development, change management systems/procedures/concepts, labeling systems, and medical device regulations (e.g., US, EU, Japan). This position must have the ability to work effectively and efficiently with all team members, have a good understanding of global labeling regulations and requirements. Strong attention to detail, written and oral communication, teamwork, and organizational skills are essential, as well as an understanding of BrioHealth Solutions products and their use. Join our team and play a pivotal role in shaping the success of our products and associated clinical trials. If you are a technical writer experienced with medical devices, and have a passion for patients, physicians, and technology, we invite you to apply.Responsibilities
- Collaborate with a team of subject-matter experts (SMEs), editors, graphic designers, and information architects.
- Edit text for spelling, grammar, style, and general clarity. Review graphics for accuracy, correct positioning, and layout. Apply proofreading techniques and markup to rigorously compare documents for accuracy and conformance to content and format.
- Optimize content organization and ensuring consistency in tone and presentation. Identify problematic usage of grammar, punctuation, abbreviations, and terminology. Identifying inconsistencies in common outputs across product lines.
- Incorporate all required changes for a product release and documenting reasons and justifications for each change. Processing manuals for review and approval according to procedures.
- Work with Clinical, Education and Training, R&D, Regulatory, Quality, Operations, and IT to develop/create labeling that complies with global and UDI labeling regulations and requirements, as required.
- Serve as the lead team member for labeling initiatives, including but not limited to: new product development, maintenance projects, and UDI tasks associated with product labels, package inserts/eIFUs, and patient cards.
- Coordinate effectively with vendors and suppliers of services (e.g., translation vendors, eIFU hosting) to ensure high quality and accuracy of content.
- Provide support during internal and external audits and reviews.
- Perform other duties as assigned.
- Bachelor’s degree in a technical area with a minimum of 1 year of experience in a labeling capacity, or 2+ years of equivalent experience in a related engineering/regulatory role in a device industry.
- Ability to build strong relationships, work effectively and efficiently with cross functional team members to create and implement labeling changes where persuasive skills, negotiation skills, and considerable tact is required to gain support.
- Proficient in the use of IFU and labeling software (e.g., InDesign, FrameMaker, Prisym, Loftware, ROBAR, IQVIA, Qarad).
- Possess an understanding of relevant medical devices and their use relating to labeling, design change control, and document control and management.
- Must have excellent written and oral communication and technical writing skills.
- Must possess exceptional attention to detail, organization, and multi-tasking skills.
- Demonstration of strong problem-solving skills; able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner.
BrioHealth Solutions Inc., is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (BrioVAD®) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. We are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe.