Regulatory Affairs Specialist

  • location: Thousand Oaks, CA
  • type: Contract
  • salary: $22.49 - $26.46 per hour
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job description

Regulatory Affairs Specialist

job summary:
Regulatory Affairs Associate

Job Summary

Under the direction of the Director of Regulatory Affairs direct and manage MEDICAL DEVICE Regulatory Affairs global activities.

 
location: Thousand Oaks, California
job type: Contract
salary: $22.49 - 26.46 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Job Responsibilities

  • Provide collaborative support for execution of global strategies. Assist and support device deliverables and management of regulatory submissions. Support device development activities for either stand-alone medical devices or combination products. Provide support to senior regulatory team members are required and supports management of device regulatory databases and project deliverables.
  • Provide regulatory support, to internal groups such as product life cycle development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned.
  • Support preparation of regulatory filings/documents in a timely manner to meet corporate objectives. Responsible for US, EU and OUS Regulatory Affairs for multiple medical device product lines filed as under 510(k), and EU Technical Files for medical devices.
  • Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives.
 
qualifications:
Education & Qualifications

  • Entry level position
  • Hiring manager will train
 
skills: Regulatory Affairs Operations, Regulatory Briefing Documents, 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.

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