Regulatory Affairs Specialists

Regulatory Affairs Specialist I — Laurel, MD, USA, 20723

Compensation
: $44.79/hr on w2

Contract period
: 12/05/2016 to 06/30/2017

Candidate will work within a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in the area of pre- and post-market regulations, submissions and new product development.

• Files / maintains regulatory deliverables
• Participates as team member on all assigned new product introductions as applicable.
• Communicates changes in existing products to applicable RA representatives for determination of the need for new/revised licenses or registrations.
• Reviews and approves advertising and promotion material ensuring it is consistent with approved claims for regulated products.
• Partners with applicable RA representative for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of license.
• Identifies any clinical data requirements for product licensing globally and ensure the requirements are documented in the compliance plan.
• Completes specific country testing and work with Region RA, and arranges for test devices and support as needed.
• Contributes to writing and editing technical documents
• Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions
• Understands and applies regulatory requirements and their impacts for submissions
• Ensures compliance with pre- and post-market product approval requirements
• Supports regulatory inspections as required.
• Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.

• Bachelor's Degree or a minimum of 4 years work experience.
• Minimum of 1 year experience working in a regulated industry
• Ability to communicate effectively in English (both written and oral).
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
• Complete all planned Quality & Compliance training within the defined deadlines.
• Identify and report any quality or compliance concerns and take immediate corrective action as required

• Minimum of 3 years’ experience in a regulated industry is preferred
• Advanced degree in scientific, technology or legal disciplines
• Regulatory Affairs Certification (RAPS)
• Statistics education and or training
• Ability to work independently in fast-paced environment with little supervision.
• Ability to adapt to constant change and influence positive change effectively.
• Team-oriented and responsive to customer needs.
• Attention to Detail and Results-Oriented.
• Ability to understand technical documentation and execute associated procedures