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

Classic Floors Ferrazzano

Shower Glass Installer Job at Classic Floors Ferrazzano

 ...Position Title: Specialties Installer (Shower Glass Installer) Department: Specialties Reports to: Specialties Manager Position Type: Regular full-time / non-exempt Classic Floors is a leading provider of shower glass, mirror, and bath accessory installation... 

eDynamic Learning

Freelance Writer for Computer Science Course Job at eDynamic Learning

Are you a dynamic educator? Were searching for Subject Matter Experts with a teaching background in Computer Science to write high school courses. eDynamic Learning is the largest publisher of elective and CTE educational resources for 6 th -12 th grades in North... 

Labcorp

Specimen Management Specialist Job at Labcorp

 ...The Specimen Management Specialist at Labcorp facilitates communication between the lab, patients, and physician offices, ensuring accurate...  ...per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or... 

SPG Green Garden Country Club

Line Cook / Assistant Executive Chef Job at SPG Green Garden Country Club

 ... Restock items as needed throughout the shift Adhere to all sanitation and food production codes JOB QUALIFICATIONS Cooking: 1 year (Preferred) We are willing to train individuals with limited experience COMPENSATION & BENFITS # Flexible scheduling... 

Certified Mobile Notary Service

New Notary Public & Signing Agent Certification License in Piscataway, NJ / Call Now 405-568-7539 Job at Certified Mobile Notary Service

Certified Mobile Notary Service ( is your ultimate One-Stop-Shop for all things related to Notary Signing Agent services! We are offering the opportunity that will help you to become a Notary Public and increase your new client base.OverviewAs a Notary Signing Agent,...