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

ProDrivers

Non CDL Truck Driver-Box Truck Job at ProDrivers

 ...providing reliable, highly qualified commercial truck drivers to meet the logistics needs of businesses across...  .... We are actively seeking a responsible Non-CDL Truck Driver to operate box trucks for regional deliveries. If you are committed to safety, efficiency, and... 

T-Rex Solutions

Intelligence Analyst Job at T-Rex Solutions

 ...in mission-focused solutions, is seeking a dedicated Junior Intelligence Analyst to join our dynamic team in Sterling, VA. At T-Rex, we play...  ...meticulous research using a wide array of government and open-source (OSINT) databases to identify status violations. In line with... 

New Perspective

Caregiver Job at New Perspective

 ...Our Caregivers are the heart to our organization. They provide daily quality care, engaging activities, and enrichment programs to our residents assisting them to Live Life on Purpose. This opportunity is a perfect fit for compassionate, patient individuals who are... 

Kaizen Advance

Non-Profit Donation Agent Job at Kaizen Advance

 ...organizations and allows you the flexibility to work from home. If you have excellent communication...  ...depending on the project Experienced agents can earn up to $0.35 per talk minute...  ...Additional opportunities for email, ticket, and chat support available with varied pay rates... 

Colorado City & County Management Association

Assistant City Manager Job at Colorado City & County Management Association

 ..., Vision, robust and accessible employee assistance program, and nationally recognized wellbeing...  ...life and disability insurance. The City of Aspen is an Equal Opportunity Employer...  ...Job Details Job Title: Assistant City Manager Hiring Range: $126,838 annually $142,7...