Regulatory Affairs Specialist - (US-NJ-Fairfield - 07004)

Minimum Education: None
Job Type: Full Time
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Responsibilities : To support all domestic and international regulatory activities in accordance with all applicable laws, regulations, Divisional procedures, and Corporate policies. The position is responsible for the planning, organization, and implementation of activities intended to procure regulatory approval for assigned new and modified product lines from initial stages of product development through final government approvals.Essential FunctionsDevelop and maintain world-wide regulatory applications for submission to regulatory bodies.These would include, but not be limited to, 510(k), PMA, IDE, European technical dossiers,and international product registrations. Maintain documentation files (hardcopy and electronic).Maintain and communicate new FDA/MDD initiatives, regulations, and guidance documentsthat may potentially affect CA's regulatory activities. Conduct periodic searches (via FOI orelectronic database information systems) for information about other IAB manufacturers thatmay be relevant to CA; e.g. 510(k)s, MDRs, EIRs, Warning Letters. etc.Participate in product development project teams to provide regulatory guidance and to ensure thatdata and technical information needed for regulatory approvals is developed and available on schedule.Provide support to PSSD Group when necessary.Assist the Senior RA Specialist and other management with the development and revision ofregulatory policies and procedures.Contribute to the accurate and efficient functioning of the RA/QA department.Conduct Quality Assurance audits. Provide support preparing for or during regulatory auditsi.e internal, FDA, Notified Body audits.

Requirements :The incumbent must have a minimum of 1-2 years experience in FDA and foreign regulatory requirements. Background in team based work environment preferred.2. Skills and AbilitiesStrong interpersonal, communication, writing and excellent organizational skills required to effectively work in a regulatory and project team environment. Strong analytical skills are required to analyze and review scientific test data for regulatory submissions. Must be a self-starter and demonstrate initiative. Strong computer skills (Word processing, spreadsheets, graphics).Are you a returning applicant.

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