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

Impact Employment Solutions

Warehouse - Middletown, PA Job at Impact Employment Solutions

 ...complete I-9 verification (E-Verify not required) Must be able to read and understand basic English for safety purposes No background check or drug test required Job Description: We're hiring 6 Warehouse Associates to work in a fast-paced distribution... 

LVI Associates

Building Envelope Senior Project Manager Job at LVI Associates

 ...Description A long standing forensic engineering and building envelope consulting firm in San Luis Obispo is looking for a Senior Project Manager to step into a key leadership role as they continue expanding across the West Coast. This is a senior seat with real influence, but... 

SynergisticIT

Entry/Junior Level Data Scientist/Python Programmer (Remote) Job at SynergisticIT

 ...tech employees have been laid off since 2022 and it's still going on. The effect of this has led hundreds of thousands of laid off tech employees competing with existing jobseekers. Entry level job seekers struggle to get responses to their applications, are getting...... 

Adient

Human Resources Manager Job at Adient

 ...Job Description Summary: Human Resources Manager plans and carries out policies relating to all phases of human resources and employee relations activities by performing the following duties personally or through subordinates in the Human Resources Department.... 

Viaero Fiber Networks

OSP Fiber Splicing Technician Job at Viaero Fiber Networks

 ...The ideal candidates will be responsible for the splicing of new cable, testing, repair of existing cable, troubleshooting. Regional...  ...business fiber plant. Drop burials. Dress and route fiber into data closets and work areas. Obtain and maintain company required...