IVDR Regulatory Affairs Consultant

Location
92121, San Diego
Salary
$75-$85/hr
Posted
May 09, 2019
Required Education
Bachelors Degree
Position Type
Full time

 

Our client, a leader in medical devices, is seeking a IVDR Regulatory Consultant. 

Scope:

This position will support a project to prepare the Toxicology Business Unit for conformity to EU In Vitro Diagnostic Medical Device Regulation (IVDR). 

Role/responsibilities:

  • Collaborate with Program Managers and other departments to determine action items and deliverables to address gaps in quality system(s) and product files.
  • Assist with program management of deliverables per project plan, if needed.
  • Assist with the creation/revision of IVDR procedures, forms and templates.
  • Initiate and route change orders to implement procedures at toxicology sites.
  • Assist with the implementation of new tech file template at toxicology sites.
  • Review and approve deliverables for technical files, such as verification and validation testing protocols and reports, post marketing surveillance reports, risk
  • Write technical files per IVDR requirements and route for review and approval.
  • Correspond with Notified Bodies to obtain certifications.
  • Correspond with EU Authorized Representative for product registrations and EUDAMED updates
  • Track and report status of regulatory affairs deliverables to management.
  • Other tasks may be assigned of a regulatory affairs nature, as needed

Skills needed:

  • Excellent organizational skills (must keep track of status of many moving pieces at the same time)
  • Good work ethic; ability to work independently (expectation that work will be completed on time with minimal supervision)
  • Good attention to detail
  • Ability to read, understand, and summarize technical and scientific information
  • Ability to interpret and apply regulations to company policies and procedures
  • Advanced user in Microsoft WORD, Excel and PowerPoint, and Adobe Acrobat DC or Pro
  • Proficient with electronic document management systems

Experience and Education:

  • B.S. or B.A. in a scientific or technical discipline
  • 5+ years’ experience in Regulatory Affairs or Quality Assurance for medical device and/or in vitro diagnostic device manufacturer
  • Prior experience managing EU technical files and/or international registrations
  • Prior experience participating on product development teams
  • Prior experience reviewing and approving design control documentation, such as verification and validation testing protocols and reports, risk management reports, scientific validity reports, and product labeling
  • Understanding of the requirements in the current EU IVD Directive and new EU IVD Regulation
  • Prior experience authoring standard operating procedures, forms and templates

Travel Requirements:

  • Candidate will need to spend several days consecutively at a time on location at Toxicology manufacturing sites to receive training, collaborate with other departments, or manage deliverables.
  • On-site presence will be more frequent early in the project and can reduce in frequency as the candidate establishes themselves. 
  • Candidate should expect to spend at least 2 weeks on site during the first month.
  • All travel expenses including airfare, hotel, meals, rental car, and gas will be paid for by the employer.