Job Summary
- Company
- Datascope
- Location
- Fairfield, NJ 07004
- Industries
- Healthcare Services
- Job Type
- Full Time
- Employee
- Career Level
- Experienced (Non-Manager)
- Job Reference Code
- 43
Regulatory Affairs Specialist
About the Job
Accountability Objective:
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 Functions:
Develop 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 documents
that may potentially affect CA's regulatory activities. Conduct periodic searches (via FOI or
electronic database information systems) for information about other IAB manufacturers that
may 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 that
data 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 of
regulatory 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 audits
i.e internal, FDA, Notified Body audits.
Position Specifications:
1. Knowledge/Educational 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 Abilities
Strong 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).
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