Randstad Regulatory Affairs Consultant in Carlsbad, California

Regulatory Affairs Consultant

job details:

  • location:Carlsbad, CA

  • salary:$70 - $90 per hour

  • date posted:Wednesday, February 6, 2019

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:669529

job description

Regulatory Affairs Consultant

job summary:

Awesome opportunity for a Sr. Regulatory Affairs Associate in Carlsbad, CA

Supports regulatory compliance performing the required activities that assure compliance with FDA regulations for class III products.

Is a subject matter expert in RA for new products, familiar with product clearances, establishing licenses, maintaining files, communicating changes, evolving regulatory landscape, quality system procedures.

location: Carlsbad, California

job type: Contract

salary: $70 - 90 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities:

  • May handle or support regulatory requests from regulatory agencies, prepare and submit product registrations and submissions to FDA and other regulatory bodies, maintain registrations and device listings, support the reporting of departmental metrics, support and backup for other Q&R functions, supports internal/external audits and regulatory inspections.

  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.

  • Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.

  • Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.

  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project, Provide significant regulatory support to ongoing PMA activities

qualifications:

Experience: Minimum 7 years professional experience in the applicable role.

Education: Bachelor's /Master's degree or equivalent. Significant leadership experience in role.

skills: *Must have extensive knowledge and experience with 510(k) submissions.

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.