Regulatory Affairs Specialist

  • location: Cary, NC (remote)
  • type: Contract
  • salary: $29 - $33.50 per hour

job description

Regulatory Affairs Specialist

job summary:
National Medical Device Manufacturer seeks Regulation Analyst

Responsible for managing the documentation process of installation and certification of Care Communication products in a timely and accurate manner. BS in Business Administration, Management or Engineering required and 2+ years of experience required. This is a remote role.

 
location: Cary, North Carolina
job type: Contract
salary: $29.00 - 33.50 per hour
work hours: 8am to 4pm
education: Bachelors
 
responsibilities:
  • Oversees, manages, processes and updates the documentation and Device History Record process of Care Communication products.
  • Review all documents related to the Care Communications Device History Records prior to submission to document control in accordance with FDA acceptance activities standards. Coordinate with members of the service organization to follow up on incomplete items.
  • Supports quality organization in Quality Systems Audits as the subject matter expert for inspection and review of Device History Record process and records.
  • Provide guidance and training on processing documentation associated with Care Communication's work orders and Device History Records.
  • Collaborate with members of the service and quality organizations to ensure compliant investigation details and resolution notes are appropriately documented.
  • Responsible for creating and maintaining exceptional customer value, employee value, and shareholder value in an environment that is demanding and ever changing due to customer expectations and practices, and developments in technology.
  • Assist in continuous improvement initiatives, projects, and/or training.
  • Assist with special projects on an as-needed basis.
  • Other duties may be assigned.
Education, Experience, and Qualifications:

  • Bachelor's Degree in Business Administration, Management or Engineering required.
  • 2-5+ years of experience required.
  • Demonstrated proficiency with MS Office (Outlook, Word, Excel, PowerPoint) and Teams.
  • Demonstrated advanced proficiency with Microsoft Excel, including but not limited to: data filters, pivot tables, VBA programming, and macros.
  • Experience with MS Dynamics CRM and JD Edwards required.
  • Must be able to perform each essential duty satisfactorily.
  • Ability to learn technical product design and operation of medical devices.
  • Ability to communicate effectively and clearly to a wide range of customers.
  • Ability to define problems, identify solutions and follow through to completion.
  • Ability to work in a detail-oriented environment.
  • Organizational Skills to prioritize multiple projects and tasks in a fast-paced environment.
#LI-BB2

 
qualifications:
  • Experience level: Experienced
  • Minimum 2 years of experience
  • Education: Bachelors
 
skills:
  • Regulatory Affairs / Compliance (2 years of experience is preferred)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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