Terumo Aortic
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Terumo Aortic
Job Title
Regulatory Affairs Associate II Department
Regulatory Affairs Overview
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Support for the regulatory side of the business to ensure compliance with corporate procedures and timely product approvals with domestic and international regulatory requirements. Position in Organization
Position in organization can be found on the Organizational Chart via the company intranet. Key Duties
Assist in the preparation of US, EU, and rest of world regulatory submissions as required. Review proposed labelling, packaging, advertising, and promotional materials after evaluating conformance to regulations. Review, edit and provide regulatory approval for project documentation. Review and analyze technical protocols, data, and reports generated by other departments. Partner with cross functional teams by providing preliminary regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities. Evaluate how design and manufacturing changes affect product registrations. Evaluate compliance to recognized and harmonized standards. Assist in SOP development, review, and initiation. Stay abreast of regulatory procedures and changes in regulatory climate. Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries. Provide Regulatory Affairs support during internal and external audits. Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA Prepare and submit medical device reports or vigilance reports. Perform various other duties as assigned. Dimensions & Limits of Authority
Requirements
Quality
Requirements Must work within requirements of company handbook and policy statements. Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system Quality Requirements
Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives. Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality. Responsible to ensure facility, processes and documentation always remain in a state of audit readiness. EH&S Requirements
Take care of your own health and safety and that of others who may be affected by your actions. Work co-operatively to highlight issues affecting Environmental Health and Safety Qualifications & Experience
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 organizational skills to maintain communications with teams and regulatory agencies. Bachelor’s degree in science or engineering (or related field) from an accredited college or university and 3 years direct experience in medical device regulatory affairs Minimum 5 years direct experience in medical device regulatory affairs if no degree. Knowledge of US and European regulatory processes, including Class III is strongly preferred. Preferred 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. Knowledge of Design Control processes and controls (21 CFR 820) Knowledge of Regulatory Standards needed in the medical device environment (ISO 13485, current revision) Awareness of Medical Device Directive and Medical Device Regulation. Seniority level
Associate Employment type
Full-time Job function
Manufacturing, Quality Assurance, and Administrative Industries Manufacturing and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Terumo Aortic by 2x Get notified about new Regulatory Affairs Associate jobs in
Sunrise, FL . Clinical Research Associate - Registered Nurse
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Regulatory Affairs Associate II Department
Regulatory Affairs Overview
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Support for the regulatory side of the business to ensure compliance with corporate procedures and timely product approvals with domestic and international regulatory requirements. Position in Organization
Position in organization can be found on the Organizational Chart via the company intranet. Key Duties
Assist in the preparation of US, EU, and rest of world regulatory submissions as required. Review proposed labelling, packaging, advertising, and promotional materials after evaluating conformance to regulations. Review, edit and provide regulatory approval for project documentation. Review and analyze technical protocols, data, and reports generated by other departments. Partner with cross functional teams by providing preliminary regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities. Evaluate how design and manufacturing changes affect product registrations. Evaluate compliance to recognized and harmonized standards. Assist in SOP development, review, and initiation. Stay abreast of regulatory procedures and changes in regulatory climate. Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries. Provide Regulatory Affairs support during internal and external audits. Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA Prepare and submit medical device reports or vigilance reports. Perform various other duties as assigned. Dimensions & Limits of Authority
Requirements
Quality
Requirements Must work within requirements of company handbook and policy statements. Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system Quality Requirements
Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives. Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality. Responsible to ensure facility, processes and documentation always remain in a state of audit readiness. EH&S Requirements
Take care of your own health and safety and that of others who may be affected by your actions. Work co-operatively to highlight issues affecting Environmental Health and Safety Qualifications & Experience
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 organizational skills to maintain communications with teams and regulatory agencies. Bachelor’s degree in science or engineering (or related field) from an accredited college or university and 3 years direct experience in medical device regulatory affairs Minimum 5 years direct experience in medical device regulatory affairs if no degree. Knowledge of US and European regulatory processes, including Class III is strongly preferred. Preferred 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. Knowledge of Design Control processes and controls (21 CFR 820) Knowledge of Regulatory Standards needed in the medical device environment (ISO 13485, current revision) Awareness of Medical Device Directive and Medical Device Regulation. Seniority level
Associate Employment type
Full-time Job function
Manufacturing, Quality Assurance, and Administrative Industries Manufacturing and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Terumo Aortic by 2x Get notified about new Regulatory Affairs Associate jobs in
Sunrise, FL . Clinical Research Associate - Registered Nurse
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr