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

Q-Cells

Sr. Compliance Risk Analyst Job at Q-Cells

 ...efficiency upgrades, backed by the PV panel manufacturer, Qcells. We are seeking an experienced and motivated Compliance Risk Senior Analyst to join EnFins Licensing & Compliance Risk team and support. This role will support EnFin and its subsidiaries across all 50... 

Wickstrom Chevrolet

Dealership Porter - Lot Attendant Job at Wickstrom Chevrolet

 ...clean new and used vehicle inventory * Maintain the dealership lot near and orderly * Shuttle customers and vehicles to and from dealership...  ...related (leaves,rain,snow) clean up of sidewalks, driveways,parking lots and vehicles * Any miscellaneous duties deemed necessary by... 

AIT Global inc.

CRM Data Developer/Analyst Job at AIT Global inc.

 ...Job Title: CRM Data Developer/Analyst Location: Dallas OR Chicago - onsite Tue, Wed, thu Must Have: 5+ years of experience in data migration analysis/development, with at least 3 years focused on data migration projects, experience with Dynamics and preferrable... 

PetSitter.com

Pet Sitter Wanted - Wanted: Skillful Overnight Care Job at PetSitter.com

 ...a good day. My family is looking for skilled pet care in Greeneville. I look forward to speaking with you!We have 3 horses, 3 cats, 3 dogs and 6 chickens and need someone to stay overnightPlease visit to view full details and to apply. Lots of jobs to choose from!

University of Miami

Medical Assistant - Doral Job at University of Miami

 ...System at Doral has an exciting opportunity for a full-time Medical Assistant 1. The University of Miami Health System will soon open the...  ...: HIV/AIDS Training for Healthcare Professionals Experience: ~ No previous experience Knowledge, Skills, and...