Regulatory Affairs Specialists I

Regulatory Affairs Specialists I

Laurel, MD, USA, 20723

$44.79/hr on w2

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.

Responsibilities

1. Files / maintains regulatory deliverables 2. Participates as team member on all assigned new

• product introductions as applicable. 3. Communicates changes in existing products to applicable
• RA representatives for determination of the need for new/revised licenses or registrations. 4.
• Reviews and approves advertising and promotion material ensuring it is consistent with approved
• claims for regulated products. 5. Partners with applicable RA representative for countries with
• license expiration requirements, to establish plans and deliverables for timely submission for
• renewal of license. 6. Identifies any clinical data requirements for product licensing globally and
• ensure the requirements are documented in the compliance plan. 7. Completes specific country
• testing and work with Region RA, and arranges for test devices and support as needed. 8.
• Contributes to writing and editing technical documents 9. Researches, analyzes, integrates and
• organizes background information from diverse sources for regulatory submissions 10.
• Understands and applies regulatory requirements and their impacts for submissions 11. Ensures
• compliance with pre- and post-market product approval requirements 12. Supports regulatory
• inspections as required. 13. Performs a broad variety of tasks in support of product and process
• design as assigned by the departmental manager.

Qualifications

1. Bachelor's Degree or a minimum of 4 years work experience. 2. Minimum of 1 year experience

• working in a regulated industry 3. Ability to communicate effectively in English
• (both written and oral). 4. Demonstrated experience and proficiency with MS Office word
• processing, spreadsheet, presentation, and database applications. Quality Specific Goals: 1.
• 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. 2. Complete all planned Quality & Compliance training within the defined deadlines.

1. Identify and report any quality or compliance concerns and take immediate corrective action as

required

Characteristics

1. Minimum of 3 years’ experience in a regulated industry is preferred 2. Advanced degree in

• scientific, technology or legal disciplines 3. Regulatory Affairs Certification (RAPS) 4. Statistics
• education and or training 5. Ability to work independently in fast-paced environment with little
• supervision. 6. Ability to adapt to constant change and influence positive change effectively. 7.
• Team-oriented and responsive to customer needs. 8. Attention to Detail and Results-Oriented. 9.
• Ability to understand technical documentation and execute associated procedures

Sandra Taylor

571-267-4186

Sandra Taylor

571-267-4186