Regulatory Affairs Specialist II

Organization
Accelerate Diagnostics
Job Location
3950 S Country Club Road
Suite 470
Tucson, AZ 85714
Benefits

Health, Vision, Dental, 401k, ESPP, Relocation, On-site Gym, Weekly Yoga, Friday catered lunches, Employee discounts, 10 paid holidays, On-site car wash, dry cleaning, pet insurance, legal assistance, HSA, FSA, Identity theft, Short/long term dissability, Employee assistance program, Basic and Voluntary LIfe/AD&D insurance, and term Life Insurance

Job Description

Regulatory Affairs Specialist II

Tucson, Arizona

Start date: Immediately

The Regulatory Affairs Specialist II will be part of the Regulatory Affairs team reporting to the Director of Regulatory. This position will perform product registrations and act as the company representative with the applicable regulatory authorities. The Regulatory Affairs Specialist II position will work with project teams to implement regulatory affairs strategies with the goal of ensuring timely product marketing authorizations. The Regulatory Affairs Specialist II will create labeling and review marketing materials for regulatory compliance. Additionally, the position will support Quality System compliance, including writing and revising relevant procedures, reviewing design documents, filing post-market surveillance reports and implementing compliance mechanisms for new regulations and regulatory guidance. The Regulatory Affairs Specialist II will work to ensure all information and data in support of marketing authorizations and post market reports is complete and accurate. This position will collaborate with personnel in multiple departments to understand the products and maintain/implement new procedures and processes.

 

ESSENTIAL FUNCTIONS:

  • Perform regulatory intelligence activities for new products and post market changes in order to identify and assess regulatory risk; then provide advice and strategy to functional and product teams on regulatory environment.
  • Perform regulatory intelligence activities to keep current on the regulatory requirements.
  • Represent Regulatory on assigned project teams.
  • Plan milestones and deliverables for assigned regulatory applications and renewals.
  • Review supporting documentation for regulatory applications and renewals for acceptability of data, procedures, and other documentation to ensure regulatory arguments are presented clearly and conclusions are supported by data and their associated risk assessments.
  • Create submissions for regulatory applications and renewal for internal review and submission, including License Applications, Submissions, Design Dossiers, and Technical Files.
  • Ensure that marketing applications and post market documentation comply with governing rules and regulations for the products.
  • Work with internal personnel to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
  • Interact and communicate with regulatory authorities about marketing applications, renewals, and post market reports.
  • Interact with and advise regulatory consultants.
  • Complete appropriate regulatory documentation for reporting of post-market events and incidents.
  • Participate in the development of Regulatory department SOPs.
  • Work with internal teams to ensure compliance with international regulations including designing and implementing training on regulatory issues and landscape.
  • Other duties as assigned.

 

MINIMUM QUALIFICATIONS:

  • Bachelor of Science in chemistry, microbiology, or related field.  Master’s degree preferred.
  • Five to eight years of IVD industry experience preferred
  • Strong knowledge of microbial identification and antimicrobial susceptibility testing desired
  • Must demonstrate understanding of IVD development and post market operations
  • Direct experience with FDA required
  • Highly organized with attention to detail
  • Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills
  • Working knowledge of electronic publishing/file management system
  • Familiarity with MS Word, MS Excel, Adobe Acrobat and PowerPoint applications
  • Exceptional self-management ability
How to Apply
About Our Organization

Accelerate Diagnostics purpose is to develop revolutionary technology for the microbiology lab.

Technologies and tests that accelerate lab results and drive better clinical outcomes for patients with serious infections.

Learn how we do it