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Job type: Permanent

Discipline: Consultant / Specialist, Labelling & Artwork, Publishing & Submissions

Location: United States

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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