This job listing has expired

Technical Writer

Dreve America Eden Prairie, MN
Find more jobs in Technical Writing ...or browse all content jobs
Job description

PRINCIPAL PURPOSE OF JOB:

Supports and strengthens Dreve's capabilities by writing regulatory submissions in collaboration with R&D and the Dreve Quality group. These submissions will ensure product safety and reliability of new UV-curable materials and photopolymerization processes.

LEVEL OF AUTHORITY:

Performs duties independently, planning own work schedule in accordance with established priorities and procedures requiring regular attention. Is responsible for sound judgment, thoroughness, and competence, where failure to perform effectively and efficiently could have a serious impact on development timelines and quality standards.

WORK ENVIRONMENT:

100% remote work with the possibility to work in the office if the employee desires. Hybrid workstyle with teamwork and independence to fulfill regulatory submissions in a timely manner.

ESSENTIAL JOB FUNCTIONS:

  1. Scheduling and hosting document review meetings in person or via teleconferencing.
  2. Participating in continuously improving established documentation processes.
  3. Proofreading and editing content created by other staff.
  4. Submitting reports to the FDA for evaluation.
  5. Develop and maintain labeling procedures that comply with FDA, GMP, ISO, and other applicable standards and regulations.
  6. Draft, edit, and review scientific protocols and documents.
  7. Collaborate with German colleagues to streamline the submission and evaluation processes.

ADDITIONAL JOB FUNCTIONS:

  1. Interpret and communicate project milestones/accomplishments via technical reports and/or presentations.
  2. Identify and develop collaborative relationship opportunities with universities or business partners to develop new capabilities.
  3. Continuous self-education of information relevant to company core competencies.
  4. Review relevant literature and identify technical conferences for continuing education opportunities.
  5. Interact with customer regulatory groups.
  6. Possibility of travel (~10%).

QUALIFICATIONS AND CAPABILITIES:

Required

  1. Ability to understand and reason with statistical data as well as communicate statistical findings.
  2. Excellent oral and written communication, research, problem-solving, and interpersonal skills.
  3. Comprehensive understanding of concise writing, minimalism, and authoring.
  4. Excellent time and project management skills.
  5. Experience adhering to a style manual and working with templates.
  6. Experience with peer editing.
  7. Previous work experience with FDA validation practices.
  8. A basic understanding of medical devices.
  9. Familiarity with the regulatory submission process.

Preferred

  1. 1+ years of experience with manufacturing processes.
  2. 1+ years of experience with UV-curable materials and processes.
  3. Bachelor’s Degree in a relevant technical discipline (i.e. Chemistry, Material Science & Engineering, Process Engineering, etc.).
  4. 1+ years of experience creating documents for projects of varying scope, type, and complexity.

About Dreve America:

DREVE AMERICA is a distributor of hearing aid and dental equipment and materials. We are a small, family-owned business with approximately 25 employees at our location. The "Dreve" family started the business in Unna, Germany and Dreve America is the primary US location in Eden Prairie, MN. Our employees' consistent feedback is that we have good flexibility to have a work-life balance. Come and join the Dreve crew!

Benefits included: medical, dental, vision, short-term disability, long-term disability, life insurance, PTO, and 401k.

Dreve America is an Equal Opportunity Employer. We do not discriminate based on race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, or other applicable legally protected classes.

Salary range USD $70k to $95k annual
Date posted 8th March 2023
Commitment Full-Time
Place of work Remote (United States)
Similar jobs
326 open job opportunities

18 new jobs added in the last week.

Popular areas
Popular cities
Hiring? We'll put your job ad in front of a growing community of content professionals. Post a job
Join our free newsletter

Each week we share peer interviews, fresh jobs, links and resources to help your career grow.

It's free. See our privacy policy.
Thanks! We'll email you weekly with new resources.