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