Terumo Medical Corporation Regulatory Affairs, Principal in Sunrise, Florida
Regulatory Affairs, Principal
Manages the regulatory side of the business to ensure compliance with corporate procedures and timely product approvals with domestic and international regulatory requirements
Develop and coordinate the preparation of medical device regulatory submissions in accordance with FDA, EU, and rest of world requirements
Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
Review, edit and provide regulatory and quality system approval for project documentation.
Review, analyze, approve, or prepare technical protocols, data, and reports generated by other departments.
Contribute to the development of world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
Partner with cross functional teams by providing independent regulatory guidance and support for strategic planning, design and development, and compliance activities.
Evaluate how design and manufacturing changes affect product registrations and implement the strategy
Evaluate compliance to recognized and harmonized standards, develop strategy for addressing gaps.
Develop procedures to ensure regulatory compliance
SOP development, review and initiation
Stay abreast of regulatory procedures and changes in regulatory climate and update department or company
Respond to requests from regulatory agencies and/or distributors
Review and provide regulatory authorization for Nonconformance Reports (NCR)
Review and provide regulatory authorization for CAPA
Provide Regulatory Affairs support during internal and external audits.
Prepare and file facility registration documents
Review and approve clinical protocols and clinical study reports
Perform various other duties as assigned
Auto req ID:
Minimum Skills and Capabilities:
Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team.
Excellent written, verbal communication and presentation skills are required.
Excellent attention to detail and ability to coordinate multiple activities simultaneously
Excellent computer skills including expertise in Microsoft Office Products
Excellent organizational skills to maintain communications with teams and regulatory agencies
Minimum Knowledge & Experience required for the position:
Bachelor's degree in Science or Engineering (or related field) from an accredited college or university and 7 years direct experience in medical device regulatory affairs
Minimum 9 years direct experience in medical device regulatory affairs if no degree.
Project Management experience or training
Comprehensive knowledge of US and European regulatory processes, including Class III is required.
Practical (hands-on) experience in a medical device regulatory environment, preparing submissions (IDEs/IDE supplements, PMAs/PMA Supplements, 510(k)s and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record is required.
Experience interacting with FDA and European Notified Bodies is required.
Experience presenting at FDA meetings is preferred.
Solid knowledge and understanding of how IDE-regulated clinical studies are performed
Comprehensive Knowledge of Design Controls (21 CFR 820)
Comprehensive Knowledge of Regulatory Standards needed in the medical device environment (ISO 13485, current revision)
Solid Knowledge of Medical Device Directive and Medical Device Regulation
Solid Knowledge of Japanese Quality System Regulations (Japanese MHLW)
Affirmative Action/Equal Employment Opportunity Statement
It is the Company's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. In compliance with the Americans with Disabilities Act (ADA), if you have a disability and would like to request an accommodation with regard to the application and selection processes (for example, the online application process or interviews) or have any questions about our website accessibility, please call 732-302-4902 or e-mail us at Staffing@Terumomedical.com.
Terumo Medical Corporation
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