Regulatory Affairs Specialist

Highly Competitive Salary
  1. Permanent
  2. Consultant / Specialist, Labelling & Artwork, Publishing & Submissions
  3. United States
Irvine, USA
Posting date: 14 Oct 2020
RA.SR.33604

Proclinical is currently recruiting for a Regulatory Affairs Specialist with a pharmaceutical company located in Irvine, CA.

Job Responsibilities:

  • Coordinate, compile, and submit Regulatory documents to competent authorities, notified bodies, Regulatory Agencies, and international business partners. Includes the preparation of key market international documents, including Technical Files.
  • Work with management to ensure rapid and timely approval of new products and continued Regulatory support of products marketed outside the US.
  • Create detailed international regulatory plans in concert with regional regulatory contacts
  • Evaluate proposed product modifications for international Regulatory impact, completing Regulatory Assessments as needed.
  • Ensure compliance with applicable international regulations and standards
  • Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
  • Assist with responses to health authority questions and other Regulatory correspondence.
  • Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
  • Update and maintain product eligibility to ensure right product/right country.
  • Requires use and application of Regulatory concepts, practices and techniques.
  • Provide solutions to extremely complex problems.
  • Provide regulatory guidance to project teams, as applicable.
  • Participate in the review and approval of international product labeling.
  • Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.

Skills and Requirements:

  • A Bachelor's degree is required, preferably in a science or technical discipline.
  • A minimum of 4 years of related Regulatory experience is preferred.
  • Familiarity with Title 21 of the US Code of Federal Regulations Parts 800-1299 (21 CFR 800-1299)
  • Experience in the application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is preferred.
  • Familiarity in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) and CE marking is required; EU MDR familiarity is preferred.
  • Experience in the application of Quality Management System Standard ISO 13485.

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

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.

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