Regulatory Affairs Specialist

Position Specific Requirements:

• Responsible for internal, domestic, and international compliance activities working under the direction of the Regulatory Affairs Director.


• Assists the Regulatory Affairs Director with regulatory strategy/plans and requirements.


• Prepares worldwide regulatory submissions/registrations.


• Participates in the review and disposition of labeling, promotional materials and product modification.


• Prepares documentation and coordinates activities related to PMA's, 510k's, and IDE's.


• Supports engineering changes through RA/QA practices by documentating the changes in compliance with Quality Systems Regulations (QSR), the Medical Device Directives, CMDR, and other International regulations.


• Participates in cross functional departmental team projects and product development activities/meetings.


• Provides support to RA Director for communication between Regulatory Agencies such as the Food and Drug Administration (FDA) and the European Notified Body.


• Responsible for FDA/ISO/MDD/CMDR compliance documentation.


• Assists in special projects as needed.


• Contributes to team effort by accomplishing related duties as requested.

Qualifications:

Bachelor's Degree in Scientific/Engineering discipline. A minimum of three years experience in a regulatory environment. Willingness to handle a number of projects simultaneously in a fast paced environment. Ability to assist in regulatory planning and strategies for domestic (510(k)/IDE/PMA) and international submissions/registrations. Ability to represent Regulatory Affairs to other departments.

For immediate consideration - please email your resume along to [email protected] along with salary expectations!

Atrium Medical Corporation offers competitive salaries, exceptional benefits, and a business casual dress code. We do not accept unsolicited Agency Resumes. Atrium Medical Corporation is an equal opportunity employer dedicated to workforce diversity and a drug and smoke-free environment. Drug screening is required.