Associate I-Regulatory Affairs - Artech Information system LLC : Job Details

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Duties:

This position will be responsible for supporting the maintenance of the Global Regulatory Affairs filing system and the Registration Tracking System (RTS) database. The position would also be responsible for Client's integration activities such as ordering required certificates and tracking of submission under Health Authority review. Continued maintenance of these systems helps to ensure compliance with global regulations and with internal Client's policies. This individual will be key to the continued compliance of the regulatory and labeling documentation.

Responsibilities:

Maintain the Global Regulatory Affairs filing system including the filing of submissions and correspondence both electronically and hard copy

Maintain the RTS database to ensure submission, regulation updates, and correspondence data is accurately entered in a timely manner

Maintain the product certificates needed for rest of world submissions, to ensure certificates are always available

Skills:

Can effectively and efficiently organize Regulatory Affairs documentation to ensure accurate filing and timely retrieval of documents, can multi-task workload to ensure tasks are completed in a timely manner, knowledge of database systems to ensure information is accurately entered and easily retrievable.

Proficient with Microsoft Office software

Excellent verbal and written communication skills

Strong organizational skills

Excellent project execution skills with an ability to multitask

Education:

Minimum requirement: Bachelor's Degree in Life Sciences or equivalent.