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MDR - Regulatory Affairs Specialist
Ref No.: 18-27856
Location: Boulder, Colorado
Start Date / End Date: 06/04/2018 to 04/30/2019
Company: Artech Information Systems
Job Title: Regulatory Affairs Specialist
Location: Boulder, CO
Duration: 12 months
Job ID: 18-27856
The Regulatory Affairs Specialist is responsible for the preparation of technical documentation in compliance with the applicable regulatory requirements and generating submissions as needed to global government agencies to support marketing approvals.
The primary focus of this position is to facilitate full compliance for multiple products with the new European Union Medical Device Regulation (EU MDR). The responsibilities include working with other functional areas to identify, modify, or create necessary documentation to meet the EU MDR. Additionally, the specialist will collaborate with global regulatory teams to ensure that the products remain compliant around the world.
  • Building and maintaining a working familiarity and practical understanding of the EU MDR regulatory requirements as well as applicable requirements from domestic and international agencies.
  • Driving the preparation, publication, quality control, and delivery of technical documentation required for full compliance with the EU MDR and associated submissions.
  • Efficiently navigating all internal document management systems to support requests from regional regulatory partners and ensure files are accurately maintained.
  • Ensuring overall compliance, contributing to multiple project workstreams, implementing creative solutions, and completing on-time execution of individual tasks to support project goals.
  • Engaging collaboratively with project teams and regional specialists which are comprised of personnel from regulatory, quality, clinical, R&D, and operation functions to ensure efficient execution of a shared strategy.
  • Working effectively with diverse cultural groups in a fast-paced environment.
  • Demonstrating familiarity and implementation of international and domestic standards.
Bachelor’s Degree in a scientific, engineering, or related discipline, required.
1-4 years of experience in the Medical device industry.
At least 1 year of experience in a Regulatory Affairs/Quality Assurance role.
Preferred Skills/ Qualifications:
  • Direct knowledge & experience with US FDA, EU Medical Device Directive (MDD) 93/42/EEC, CE mark process, and industry standards and policies.
  • Exposure to EU Medical Device Regulation (EU MDR) 2017/245 a plus.
  • Strong technical writing and verbal communication skills.
  • Computer literacy, proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat Pro, etc.
  • High learning aptitude and adaptability with software systems.
  • Excellent organizational and multi-project management skills and attention to detail.
  • Ability to work in a fast-pace environment.
  • Ability to multi-task and prioritize effectively.
  • Ability to manage small scale projects to completion.
Rajiv Maruthi