Regulatory Affairs Specialists I

BCforward; Laurel (MD); On-site; USD 61,702; Full time

Job summary

A leading staffing and IT solutions firm is seeking a Regulatory Affairs Specialist I in Laurel, MD. This role involves maintaining regulatory deliverables, participating in new product introductions, and ensuring compliance with regulations. The ideal candidate has a Bachelor’s Degree or 4 years of experience, at least 1 year in a regulated industry, and proficiency in MS Office. This position offers competitive pay at $44.79/hr on W2.

Qualifications

• Minimum of 1 year experience in a regulated industry.
• Minimum of 3 years’ experience in a regulated industry is preferred.
• Statistics education and or training.

Responsibilities

• Files and maintains regulatory deliverables.
• Participates as a team member on new product introductions.
• Communicates changes in existing products to RA representatives.
• Reviews advertising to ensure compliance with claims.
• Partners for timely renewal of licenses.

Skills

Ability to communicate effectively in English

Demonstrated experience with MS Office

Attention to Detail

Ability to adapt to change

Team-oriented

Education

Bachelor's Degree or 4 years of work experience

Regulatory Affairs Certification (RAPS)

Advanced degree in scientific, technology or legal disciplines

Job description

BCforward began as an IT business solutions and staffing firm. Founded in 1998, BCforward has grown with our customers’ needs into a full service personnel solutions organization. BCforward’s headquarters are in Indianapolis, Indiana and also operates delivery centers in 20 locations in North America as well as India and Puerto Rico. We are currently the largest consulting firm and largest MBE certified firm headquartered in Indiana.

Job Description

Regulatory Affairs Specialists I

Laurel, MD, USA, 20723

$44.79/hr on w2

12/05/2016 to 06/30/2017

Responsibilities

• 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 works 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.

Qualifications

• 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.

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

Characteristics

• 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.

Characteristics

• 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.