Position is a support role requiring more work direction whereby worker follows generally defined procedures. Worker performs chemical, biological, physical, and/or mechanical analyses and tests required for research, development, or quality control of processes and products. Assists with compiling, analyzing, interpreting, and documenting results Ability to follow procedures and methods and to work well on a self-directed team is required. Good mechanical aptitude and skills as well as experience and specific training in inspection procedures and/or the product line are required. Experience in a lab or technical environment is preferred. Must be computer literate with good communication and time management skills.
Additional Job Description
Primary Responsibilities include but are not limited to the following:
Maintains/updates existing company CERs according to internal SOPs.
Contributes toward post-market clinical safety and risk management programs as requested.
Manages timelines and communication to ensure deliverables and milestones are met.
Ensures compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. EU MDR).
Conduct scientific literature reviews and compile reports, such as annual literature updates and periodic safety updates, to provide to global regulatory agencies
Gather relevant documents for writing of CER
Follows a selected number of clearly defined procedures under general guidance. Handles inquiries of moderate scope and complexity.
Designs and writes technical documentation
Conforms to department standards of formatting, information design, and usability. Uses appropriate tools and software programs for writing and publishing documents based on the project and industry standards.
Serves on cross-functional teams responsible for product development, attends team meetings, and maintains open communication between the team and other departments. Edits work for other writers. Fosters a respectful, cooperative work environment.
Follows a variety of clearly defined procedures under general guidance. Works independently, although the scope for discretion is limited and the output is reviewed periodically while in progress. The work priorities are defined with the manager/supervisor.
Uses relevant theories and practices to provide guidance and/or training to support level co-workers within the same or job-related work group.
Handles inquiries of moderate scope and complexity. Uses basic analytical skills to interpret information, examine variables, draw conclusions, and assess alternative methods. Most complex problem solving may require the use of increased judgment to handle some variations in conditions or operations, making decisions based on selecting from alternative courses of action using greater adaptation to circumstances when necessary.
Decisions or actions may impact the operational effectiveness of work operations, schedules, or performance goals
Minimum of Bachelors Degree or equivalent in engineering, scientific or medical discipline
Minimum 1 year of relevant working experience