Associate I-Regulatory Affairs

Artech Information System LLC; Emeryville (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading IT staffing company in Emeryville is looking for a qualified candidate to support the maintenance of their Global Regulatory Affairs filing system and RTS database. The role emphasizes effective organization, knowledge of compliance, and project execution skills. A Bachelor's Degree in Life Sciences or equivalent is required, along with proficiency in Microsoft Office and excellent communication abilities. Join this firm to contribute to regulatory compliance and documentation management.

Qualifications

• Must possess a Bachelor's Degree in Life Sciences or a related field.
• Experience with regulatory affairs documentation and compliance.
• Ability to multi-task and manage workload effectively.

Responsibilities

• Maintain the Global Regulatory Affairs filing system.
• Ensure accurate entry of data in the RTS database.
• Manage product certificates for submissions.

Skills

Organizational skills

Communication skills

Microsoft Office proficiency

Project execution skills

Database system knowledge

Education

Bachelor's Degree in Life Sciences or equivalent

Job description

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.

Job Description

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

Qualifications

Education:

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