Regulatory Affairs Specialist Job at Atrium Medical, Hudson, NH

VDhaRWhvdk1zY1hzNE9LVDZrNGRxV0pYY0E9PQ==
  • Atrium Medical
  • Hudson, NH

Job Description

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. Atrium Medical

Job Tags

Casual work, Immediate start, Worldwide,

Similar Jobs

Lawton Standard

Production Team Member Job at Lawton Standard

 ...learning various processes within the foundry. No prior foundry experience is required-well train you. Youll be part of a team producing...  ...castings for industries such as mining, marine, HVAC, and oil & gas. This is a hands-on position with opportunities to learn,... 

Adobe

Principal Digital Strategist, High Tech - Software Job at Adobe

Principal Digital Strategist, High Tech - SoftwareAbout AdobeAdobe is at the forefront of digital innovation, raising the bar with powerful solutions for the creative and marketing ecosystem such as Creative Cloud, Experience Cloud, Firefly, and Express. We are committed... 

ERCOT

Audio Video Technician Lead Job at ERCOT

 ...routine and special services and installation on a variety of audio visual equipment, software applications and systems. Assist with...  ...manuals and specifications Works with vendors and data center technicians on A/V drawings and rack wiring designs Identifies and... 

Air Products

Summer PhD Intern/Co-op - Chemical Engineering (2026) Job at Air Products

 ...and applications expertise to customers in dozens of industries, including refining, chemical, metals, electronics, manufacturing, and food and beverage. Air Products develops, engineers, builds, owns, and operates some of the world's largest industrial gas projects,... 

IDR, Inc.

Inventory Coordinator Job at IDR, Inc.

 ...Job Description IDR is seeking an Inventory Coordinator to join one of our top clients in Auburn, MA. This role is pivotal in orchestrating the seamless execution of events, from initial planning to post-event follow-up. If you are looking for an opportunity to join...