Regulatory Affairs Professional 4
Job Posting for Regulatory Affairs Professional 4 at Cube Hub Inc.
Description
Job Posting Description Regulatory Affairs Professional 4
Position Description
Key Responsibilities: "Senior Professional" Positions which need senior professional expertise, with extensive functional, commercial and/or technical knowledge in an area of competence. They integrate analysis, development, testing and implementation. They interpret and functionally influence policy and guidelines in their area of business / technology, and develop processes and systems to deliver functional objectives. They typically plan own work according to targets agreed, within a quarterly up to an annual cycle, by integrating resources in a project driven environment. They provide functional advice and guidance to colleagues and customers. A chartered professional qualification or equivalent is typically associated with grades (though not necessary).
Experience: 5-8 years.
Product Registration Experience
Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files
Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.
Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO 10993-1 as evidenced by coursework or submissions that required use of each standard
Teamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.
Experience with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.
Additional Details
Job Posting Description Regulatory Affairs Professional 4
Position Description
- Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements
- Identifies, analyzes and implements country specific requirements necessary for product related submissions.
- Recommend strategies for earliest possible approvals for marketing applications
- Performs regulatory projects or acts as a member of the project steering group.
- Submits required documentation/information to local authorities or Client/Varian internal.
- Initiates and escalates necessary activities if deviations are identified.
- Ensures creation of adequate documentation for audits/inspections.
- Performs training within the organization in country specific regulatory requirements, if applicable.
- Write and maintain submissions procedures, work instructions and templates relevant for maintaining regulatory compliance.
- Performs review of promotional material for regulatory compliance according to country specific requirements.
Key Responsibilities: "Senior Professional" Positions which need senior professional expertise, with extensive functional, commercial and/or technical knowledge in an area of competence. They integrate analysis, development, testing and implementation. They interpret and functionally influence policy and guidelines in their area of business / technology, and develop processes and systems to deliver functional objectives. They typically plan own work according to targets agreed, within a quarterly up to an annual cycle, by integrating resources in a project driven environment. They provide functional advice and guidance to colleagues and customers. A chartered professional qualification or equivalent is typically associated with grades (though not necessary).
Experience: 5-8 years.
Product Registration Experience
Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files
Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.
Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO 10993-1 as evidenced by coursework or submissions that required use of each standard
Teamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.
Experience with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.
Additional Details
- Regulatory Affairs Professional 4|TX
- Does this worker qualify for overtime? : Yes
- Scorecard Category : Professional
- Commercial Title : Sr. Regulatory Affairs Specialist
- Vaccination Notice : This position requires Contingent Workers to be fully vaccinated against COVID-19 unless they are granted a medical or religious exemption.
- Is this position for a pre-identified (PAYROLLED) candidate? : RECRUITED
- If this is a pre-identified (PAYROLLED) candidate, please see note below and provide the following: : Name: Email Address: Phone Number: Please also attach the pre-identified candidate's resume
- Will this contingent worker require a computer or systems access or utilize a timeclock? : Yes
- Time System : NA - Time is not tracked in any system
- Timeclock/Shift : NA - Time is not tracked in any system|NA
- Enter Shift Start and End Time : 8am-5pm
- Is there potential for this to convert to a full time position? : No
- Non-Employee Class : Temporary Agency Worker
- Will the worker be required to travel for Client? : No
- Is there potential for this assignment to be extended beyond 13 weeks? : Yes
- Type of assignment : Full-time
- Healthineers Vaccination Statement : Healthineers positions within applicable states require candidates to be fully vaccinated or obtain approval of special medical or religious exemption within three days of worker start date.Currently not applicable in the following states: Alabama, Florida, Iowa, Kansas, Montana, North Dakota, Tennessee, Texas, and Utah. States subject to change
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