Regulatory Data Specialist 1

Posting Date 1 month ago(9/17/2020 9:45 AM)
Requisition ID
2020-7886
Job Location(s)
West Lafayette IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Regulatory Affairs

Overview

The person in this position will form part of the Regulatory Affairs department. Primary functions will include managing Regulatory Affairs data collection, data storage system needs and the delivery of regulatory database projects.

Responsibilities

  • Learn and remain current with global regulatory requirements for Unique Device Identifier (UDI) and medical device labeling.
  • Liaise between Labeling team and Regulatory Affairs, translating regulatory/UDI requirements into compliant medical device labeling.
  • Manage Unique Device Identifier (UDI) databases and lead process improvement efforts. Liaise between IT systems and Regulatory Affairs to help translate business and regulatory requirements into user-friendly solutions.
  • Represent Regulatory Affairs in local and global project teams, ensuring compliance with regulatory requirements and guidelines to regulatory operations.
  • Author and maintain procedures/instructions describing regulatory systems/tools. Train team members in using the systems as needed.
  • Maintain domestic regulatory affairs files.
  • Support with the assembly, review, and submission of regulatory documents to obtain and maintain marketing clearance for CBI products.
  • Participate in external audits as required (FDA & TUV).
  • Assist Management with other corporate duties when required.
  • Remain current and apply the understanding of FDA-ISO 13485 and Quality System requirements in carrying out duties.

Qualifications

  • Bachelor’s degree or equivalent technical experience in Management Information Systems, Computer Information Systems, life sciences or engineering preferred.
  • Experience/advanced skills using computer software (e.g. MS Excel or Access) to create and manage large databases required.
  • Experience or interest in medical device regulatory affairs preferred. Ability to self-learn and good reading comprehension skills required.
  • Must have attention to detail and excellent organizational skills.
  • Able to present a professional and personable demeanor in phone, written, and face-to-face communications. Good verbal and written communication skills.
  • Ability to work well with a team.
  • Ability to handle multiple and changing priorities along with fluctuations in workload.
  • Experience in basic office equipment; i.e., fax, copier, computer, printers, phone systems, etc.

Physical Requirements/Work Environments

  • Sign non-competition and confidentiality agreements. Compliance with all policies of the company including without limitation the COOK Employee Manual, COOK Code of Conduct, COOK Electronic Information Policy, HIPAA regulations, and COOK Policy & Guidance on Interaction with Healthcare Professionals.

 

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