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

Nevada Staffing

SHEET METAL MECHANIC (AIRCRAFT) Job at Nevada Staffing

 ...divh2Job Responsibilities/h2pYou will remove fixed sheet metal and composite structures from aircraft and disassemble structural and...  ...perform common tasks including: 1) Performing metal repair, fabrication, planning, laying out, designing, and assembling/dissembling... 

ERM

Consulting Director, Regulatory Analyst (Utilities/Power/Renewables) (Walnut Creek) Job at ERM

 ...Consulting Director, Regulatory Analyst (Utilities/Power/Renewables) Are you ready to lead transformative environmental projects that power communities and drive sustainable innovation? ERM is seeking a visionary Consulting Director, Regulatory Analyst (Utilities/Power... 

Obran Cooperative

Dedicated Route Freight Truck Driver (CDL/Non-CDL) Job at Obran Cooperative

 ...looking for a qualified Freight Driver to join our team! You will be...  ...operating a 16' to 18' box truck with a capacity of at least 24...  ...Vehicle Weight (GVW). This is a dedicated client route that operates...  ...problem solve Familiarity with local streets, neighborhoods, and... 

Methodist Healthcare Ministries in

Triage RN (WHWC) -Registered Nurse Telephone Triage Job at Methodist Healthcare Ministries in

Triage RN (WHWC) - Registered Nurse Telephone Triage (Finance)Essential Duties:Supports and practices the mission and philosophy of Methodist Healthcare MinistriesAnswer phone calls for Methodist Healthcare Ministries' multi-disciplinary health & wellness center locations... 

Labor Biz Market

Entry Level Communications Agent Job at Labor Biz Market

 ...workforce logistics to ensure our clients success. Position Overview We are seeking a motivated and enthusiastic Entry Level Communications Agent to join our dynamic team. This role is an excellent opportunity for individuals looking to start their careers in communications...