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Regulatory Affairs Specialist

Company: GPAC
Location: Philadelphia
Posted on: November 22, 2021

Job Description:

Regulatory Affairs Specialist Role with a World-Class Medical Device Company!! Regulatory Affairs Specialist Duties and Responsibilities:

  • Support new product development and commercial programs by interacting with cross-functional project teams in the preparation, review, and completion of global regulatory strategies and required documentation to support global regulatory submissions.
    • Focus on authoring, maintenance, and tracking of dossiers for submission to global regulatory agencies including FDA premarket notifications [FDA 510(k)], EEU Technical Files, Health Canada, APAC, and Latin America licenses.
      • Preparation, review, and completion of global regulatory strategies for establishing and maintaining quality system compliance to global regulations, directives and standards including FDA QSR, 93/42 EEC, ISO 13485, MDSAP, Health Canada, ANVISA, INMETRO, NMPA, and other countries in Latin America and the APAC region.
        • Maintain a working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD, and others as required. Regulatory Affairs Specialist Requirements:
          • Bachelor's Degree in Life or Natural Science (or equivalent)
            • Experience in FDA and Global cGMP, and other regulatory compliance requirements.
              • 5+ years of experience in QA/RA with a demonstrated progression in leadership experience in the Medical Device or Pharmaceutical industry.
                • Effective verbal and written communicator.
                  • Technical expertise in quality control, quality systems, quality assurance, manufacturingtechnologies, and product function as well as governing laws and regulations.
                    • Proven experience and success record with global regulatory interactions and affairs including USA, EU MDR, ISO 13485/MDSAP, Latin America, and APAC region regulations. Regulatory Affairs Specialist Benefits:
                      • Medical, Dental, Vision, 401k, life insurance, short-term and long-term disability ***For more information on this opportunity, contact Millisa Reynolds directly at **Resumes may be confidentially emailed to Medical Device Companies: If your team needs any position(s) filled, we can also assist in finding qualified talent. Contact Millisa directly or All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 31 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

Keywords: GPAC, Philadelphia , Regulatory Affairs Specialist, Other , Philadelphia, Pennsylvania

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