Regulatory Affairs Consultant - FDA Labeling

  • location: Carlsbad, CA
  • type: Contract
  • salary: $90 - $120 per hour
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job description

Regulatory Affairs Consultant - FDA Labeling

job summary:
We are seeking a Regulatory Affairs Consultant with a specialty and knowledge in Labeling of medical devices and accessories in Carlsbad, CA.

In this role, you will oversee activities to complete sustaining product labeling changes, update labeling related SOP's as needed to streamline and bring efficiency to the process.

location: Carlsbad, California
job type: Contract
salary: $90 - 120 per hour
work hours: 8 to 5
education: Bachelors
Position Responsibilities:

Assist in the development of the instructional wording on the outside of the packaging, medical devices and accessories.

Redline markup/annotate drawings and artwork, create clean artwork in support of engineering changes

Prepare and Review Engineering Change Orders for Regulatory compliance relating to drawings and artwork associated with labeling changes.

Liaise with Regulatory Affairs members and other cross-functional teams (e.g., supply chain, legal, medical, pharmacovigilance) to ensure the accuracy of all information included on the label or in the labeling.

Participate in project management meetings as needed.

Monitor output and workload of labeling specialist to ensure alignment to business objectives

Working with manufacturing to set up printing formats based in Loftware or applicable printing software.

- At least 10 years labeling experience creating, editing and releasing product and packaging labels for medical devices

skills: Job Requirements:

- Must be fully conversant with different label creation tools such as bartender, loftware, etc.

- Must be fully conversant with UDI regulations and European Union label and symbol requirements

- Must be fully conversant with GS1-128 Labeling Formats

- Strong understanding of labeling regulations and requirements, ability to project manage labeling projects, demonstrated ability to proactively manage product labeling needs for new product development and sustaining products, strong emphasis on exceeding customer expectations, while maximizing value and maintaining FDA/ISO and other regulatory compliance.

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.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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