Regulatory Affairs Specialist

Highly Competitive Salary
  1. Permanent
  2. Consultant / Specialist
  3. United States
Irvine, USA
Posting date: 01 Apr 2020

Proclinical is currently recruiting for a Regulatory Affairs Specialist with a Medical Device company located in Irvine, CA. A successful candidate will ensure computer skills -the candidate will be entering information into complex premade excel sheets and experience in the Regulatory space, specifically completing international documentation and registrations.

Job Responsibilities:

  • Responsible for ensuring personal compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
  • Coordinate with internal and external sources to accomplish activities
  • Fulfill requests for all product documents, certificates, or information for registration or re­ registration from all international affiliates
  • Support Tender requests from all international affiliates for (RALI) Regulatory Affairs Lifecycle Innovation Unit, and Franchise Business Unit
  • Work with Regulatory Affairs, Manufacturing, R&D, Quality, and other areas to obtain copies of signed documents for registration. Responsible for communicating business related issues or opportunities to next management level
  • Prepare Powers of Attorney, Letters of Authorization and other legal sensitive documents required by international affiliates for registration, to be signed by JJSI Manager/Director level or above
  • Provide back-up support for third-party audits by providing regulatory documents to Auditors, when requested by Management
  • Generate excel reports from Request Manager database to track affiliate requests
  • Provide information or documentation for all international affiliates from cPDM, Sharepoint, or TRIM databases
  • Prepare documents or certificates for embassy legalization from our outside service company
  • Prepare all documentation and information to obtain {CFG) Certificate to Foreign Government or (COE) Certificate of Exportability, from the FDA (CECATS) for all business units
  • Coordinate with SMEs (Subject Matter Experts) for product information or documentation requested from all international affiliates
  • Coordinate with OEMs (Outside Manufacturers) for all product information, legal documents, or certificates requested from all international affiliates

Skills and Requirements:

  • University/Bachelor's Degree or Equivalent
  • 2-4 years of experience in Regulatory Affairs and in the medical device industry
  • Solid computer skills

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134 or upload your resume on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.