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

Self Regional Healthcare

Patient Care Technician I, NRS, AAMC, Resource Pool, Nights Job at Self Regional Healthcare

 ...NRS, AAMC, Resource Pool, Nights The Nursing Assistant provides compassionate patient...  ...Minimum Experience Requirement Two years prior experience in a physician office or...  ...impact on billing. Knowledge of the prior authorization process. Knowledge of medical... 

BayOne Solutions

Desktop Support Technician Job at BayOne Solutions

 ...troubleshooting/repair/resolution for all endpoints (laptops, desktops, kiosk machines, and mobiles/tablets) Experience with: Deploying...  ...issues Qualifications ~3+ years in a fast-paced Desktop Support role, where you handled changing priorities, escalations, and a... 

Lancesoft INC

psychiatrist Job at Lancesoft INC

 ...Job Description The Psychiatrist will provide outpatient coverage for adult patients at the Outpatient Mental Health Clinic Applicants should possess excellent clinical skills, communication skills, and a strong commitment to providing care that is team oriented... 

TransUnion

Accounting Internship - Summer 2026 Job at TransUnion

 ...pioneering products and cutting-edge technology. Our Summer Internship Program at TransUnion will allow you to use & develop the...  ...What You'll Bring: Currently pursuing a Bachelors Degree in Accounting or Finance with a graduation date of June 2027 or earlier Proficiency... 

Compass Group

AUDIO VISUAL TECHNICIAN (ON CALL) Job at Compass Group

 ...We are hiring immediately for on call AUDIO VISUAL TECHNICIAN positios. Location : Pfizer/Metlife - 2002 North Tampa Street, Tampa, FL 33602. Note: online applications accepted only . Schedule : On call schedule. Hours and days may vary. Further details...