Technical Writer with Change Controls
3 weeks ago
RQMIS, Inc. is a fast growing, medical device/biotechnology consultancy with as focus on regulatory strategy/submissions, clinical study design/management and quality systems design/compliance/auditing. We are looking for an experienced Technical Writer for our Amesbury, MA office. This person shall work with our consultants in supporting projects involving regulatory submissions, quality system documentation and/or clinical study material. This is a wonderful opportunity for someone who enjoys a variety of projects, and working with a dynamic team of people in a thriving company.
Title: Technical Writer with Change Controls (Experienced with Medical Device Products)
The Technical Writer will provide overall management of technical writing projects of clients’ needs in the areas of design, create and maintain of technical documentation. Technical documentation includes product labeling, regulatory submissions, quality system procedures, forms, clinical study documentation, change controls support and so on. Provide training to clients and internal staff on technical writing, good documentation practices and use of Microsoft and Adobe programs in document production.
POSITION DUTIES & RESPONSIBILITIES
· Organize material and finish the given material with required style, terminology, clarity and order.
· Coordinate with Project Manager and client representatives to establish technical specifications required for publication.
· Work with Change Owners on Document and Records Controls process change implementation and ensure changes are tracked accordingly
· Undertake extensive data analysis.
· Involvement in the development of product documentation.
· Submissions 510(k), IDE, PMA, etc.
· Quality System Documentation (SOPs, Flowcharts, etc)
· Technical file creation/maintenance.
· All documentation conversion.
· Participate in other projects as needed.
EDUCATION & PROFESSIONAL EXPERIENCE
· Bachelor’s Degree or in the process of attaining such a degree
· Strong computer skills, including Word, Excel, Visio and Adobe Professional
· Excellent oral and written communication skills
· Ability to manage several tasks simultaneously
· Experience with creating technical documentation
· Ability to communicate technical concepts to a non-technical audience
· Ability to manage several tasks simultaneously
· Experience with creating technical documentation
· Ability to communicate technical concepts to a non-technical audience
Company DescriptionRQMIS Inc is located north of Boston Massachusetts area is a fast growing medical device/ biotechnology consultancy with focused in three principle areas, regulatory strategy/submissions, clinical study design/management and quality systems design/compliance. RQMIS Inc has been providing companies with strategic guidance on how to effectively navigate the FDA, UK and EU regulations for over 25 years in around the world.Company DescriptionRQMIS Inc is located north of Boston Massachusetts area is a fast growing medical device/ biotechnology consultancy with focused in three principle areas, regulatory strategy/submissions, clinical study design/management and quality systems design/compliance. RQMIS Inc has been providing companies with strategic guidance on how to effectively navigate the FDA, UK and EU regulations for over 25 years in around the world.-
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