Vispero is the world’s leading assistive technology provider for the visually impaired and owner of the brands Enhanced Vision, Freedom Scientific, Optelec, and TPGi. All the Vispero brands have a long history of developing and providing innovative solutions for blind and low vision individuals, helping them to reach their full potential.
Technical Writer Consultant – MDR/MDD/CER/ISO At Vispero, you’ll be part of a global team enhancing solutions that make a difference in people’s lives. Vispero is the world’s leading assistive technology provider for the visually impaired and owner of the brands brands Enhanced Vision, Freedom Scientific, Optelec, and TPGi. All the Vispero brands have a long history of developing and providing innovative solutions for blind and low vision individuals, helping them to reach their full potential.
The Technical Writer Consultant (TWC) is an 8-12 month contracted position with the Vispero Compliance team, and participates in the planning, and development of the production schedule for our Clinical Evaluation Reports, ISO implementation project, and other Medical Device Regulation required documentation for our products. Primary responsibilities include working with a diverse team to assist in writing and reviewing the Clinical Evaluation Reports (CERs), ISO documentation generation, and Risk Management documentation according to our established procedures and templates. Vispero’s documentation will be completed by utilizing existing templates and protocols under the direction of Management. The ideal TWC candidate would have medical or ISO writing experience, has worked with diverse teams synthesizing the data they provide, an understanding of literature research methodology (i.e. systematic literature search, PICO, etc.), and knowledge of the FDA and/or European medical device guidelines/regulations (such as MEDDEV and MDD/MDR). Experience creating CERs and/or with a ISO regulated environment is a plus.
Analytical thinking and inquisitive mindset for investigations and problem solving
Excellent communications skills, both written and verbal with the ability to understand and effectively communicate scientific and compliance regulation information; respond to inquiries and address needs of key stakeholders
Well organized and attentive to detail
Excellent time management skills
Demonstrated ability to build positive constructive relationships with cross-functional team members internally and externally
Demonstrated high level of personal integrity, communication and flexibility.
Understanding of the highly regulated medical device industry environment.
Understanding of the legal and regulatory environment.
Strong work ethic and commitment to serve internal and external clients
Proactive with a sense of urgency in managing job responsibilities
Energy, focus, motivation and debate-friendly
Team player, “can-do” attitude and excellent interpersonal skills
The TWC would divide their time assisting the Medical Researcher, Engineering, & Quality as follows
33% Medical Researcher CER Development and Writing/Assistance. Gathering information both internal & external. Compiling, analyzing, grading literature – guidance/examples/keys provided. Writing of CER – guidance/examples/keys provided
33% Engineering Tech Document Writing/Assistance. Gathering information both internal & external. Compiling, modifying, updating, creating documents – guidance/examples/templates provided. Inter-departmental collaboration (Instructions & Label generation) guidance/examples/templates provided. Assisting Doc Control with PLM (PN# & doc generation), as needed
33% Quality ISO Doc Writing/Assistance. Inter-departmental collaboration (ISO documentation generation) – guidance/examples/templates provided. ISO Implementation project assistance, as needed
Assist in developing and managing the construction of the CER, creating/updating Risk Management documentation under guidance of MDR team
Deliverables include CEP, CER and other MDR completed templates/spreadsheets required for the document construction.
Meet weekly to communicate timelines and ensure critical information is transmitted to relevant parties in a timely manner.
Work among the various departments to request and obtain data related to the construction of the CER, and ISO documentation.
Perform periodic document reviews with the stakeholders such as the Project Manager, Medical Researcher, Sr. Compliance and Sustaining Engineer, and the Quality Department Project Manager.
Work within the PLM system to create new/revise current documentation as needed
Participate in and/or perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature and state of the art to support assigned product lines.
Ensure deliverables are consistent with global regulations and guidelines, as well as internal policies and procedures.
Work with the Project Manager and/or Medical Researcher to schedule meetings and keep track of the progress and outcomes of the projects.
Participate in scheduled update or kick offs meetings, updating teams on progress.
Track and account for time and their own project activity.
Bachelors or above science / healthcare degree preferred, or 3+ years related medical device experience or ISO writing experience
Experience with literature search protocols for obtaining clinical research experience in the device or pharmaceutical industry.
Some knowledge of MDD, MDR and MEDDEV regulations and guidance
Experience with Microsoft applications
Experience with medical or ISO writing preferred
If you have a passion for excellence and want to work with an outstanding team of experts, working in an exciting, challenging, fast paced environment for the world’s leading assistive technology company, please send your resume to email@example.com.
Vispero actively seeks to develop greater levels of diversity in our workforce and in our pipeline of future employees. We are committed to attract and retain candidates who have a passion for their work and encourage all individuals to apply. Vispero is an Equal Opportunity Employer.