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Regulatory Affairs Specialist

Company: Exelint International
Location: Redondo Beach
Posted on: May 2, 2021

Job Description:

Job DescriptionLaws & Regulations, Policies & Procedures

  • Ensure company compliance with all industry regulations and laws pertaining to company business, including products, policies and procedures
    • Be up to date as information on new regulations and laws become available
    • Have extensive knowledge of state, federal and international regulations
    • Assists in the implementation of international and domestic regulatory strategies
    • Help organization navigate the regulatory life cycle of a product or project
      • Perform internal audits, coordinate and manage all aspects of external audits
        • Responsible for implementing training guidelines and training all members of the team on important regulations
        • Communicate information about federal and state regulations to different groups in the company
        • Generate ideas and implementation plans for the organization in regard to regulatory compliance
        • Help improve and strengthen the company---s Quality Management SystemResearch, Compile and submissions
          • Research, prepare, compile, and coordinate the submission of applications and appropriate technical documents to foreign and domestic regulatory agencies
            • Prepare regulatory strategies and identify regulatory requirements for submissions to ensure the efficient approval and registration of products
            • Prepare responses to action letters and other agency requests
            • Assemble, prepare and submit original registrations, amendments, variations, maintenance reports and other documents to regulatory agencies
            • Conduct research to support regulatory submissions
            • Maintain and safe guard well organized application documents so the company's regulatory strategy and actions may be defended with regulators
            • Serve as a liaison with regulatory agencies
              • Research and fix regulatory affairs related problems on behalf of management
              • Keep applications updated and edited as necessaryCustomers, Vendors, and other constituents
                • Respond to common inquiries from customers, prospective customers, and regulatory agencies
                • participate in customer complaint reviews to ensure global regulatory compliance, address all complaints and file all necessary paperwork
                • Act as Liaison and work with factory/manufacturing vendors and customers to obtain and communicate regulatory affairs Questions and Answers
                • Act as liaison and work with consultants and advisors as necessary to fulfil and complete both ad-hoc and planned projects
                  • Collaborate with other departments to obtain documentation for regulatory purposes
                    • Write reports and present them to upper management
                    • Be well educated about the products and projects being completed--Required skills
                      • Medical Devices
                      • Project Management
                      • Regulatory Compliance
                      • Competency in Quality Assurance / Quality Control
                      • Technical Writing--Credentials & Experience:
                        • 5+ years of experience in medical devices
                        • Experience in FDA submissions, notably 510K submissions
                        • Experience with ISO, EU, Health Canada and other international regulatory agencies
                        • Bachelor's degree in scientific development or a related field
                        • Master---s degree in Science is a strong plus
                        • Must have excellent verbal and written skills$80,000-$100,000/year*- subject to credentials, experience, and proven track recordCompany DescriptionEstablished in the 1980s, Exelint International has been delivering state-of-the-art products and superior customer service to the medical and veterinary markets. Headquartered in sunny Redondo Beach, California, our offices are 15 minutes to the Manhattan Beach pier. We value culture, diversity, and teamwork with our employees. Our professional atmosphere is a friendly environment with an open-door policy.Our long-term goals are to continue strengthening our global presence. We seek forward thinking individuals who are interested in being part of that effort.EXELINT INTERNATIONALTM is a privately held corporation that has been manufacturing and distributing disposable medical and animal health care products since the 1980---s. EXELINT INTERNATIONAL--- s comprehensive product line features both safety and conventional disposable hypodermic products. In addition to our standard syringes and needles EXELINT INTERNATIONAL also offers blood draw sets, port access (Huber) infusion sets, IV administration sets and much more. Our diverse product line allows us to reach many market segments in both the medical and animal healthcare industries without losing focus on our main objective, customer satisfaction. EXELINT INTERNATIONAL products are sold exclusively through authorized distributors including many national U.S. distributors. Dedication to total customer satisfaction through our product quality and customer service has contributed to our continued success as manufacturing, importing, and exporting of medical and surgical supplies.

Keywords: Exelint International, , Regulatory Affairs Specialist, Other , Redondo Beach,

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