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

Mohawk Industries

TILE CARRIER - 2nd SHIFT Job at Mohawk Industries

 ...This is 2nd shift position working Monday to Thursday from 3:30pm to 2:00am. The hourly rate of pay is $20.43. The Tile Carrier operates and ensures a mounting line is supplied with tile. Major Functions and Scope: Feeds finished tile onto conveyers to... 

Boston Party Adventures

Party Characters/Actors (Boston) Job at Boston Party Adventures

Boston Party Adventures has been serving smiles and unforgettable memories to New England families since 1981. We are a Boston-based company in Massachusetts, specializing in providing a wide range of entertainment services. With a strong focus on creating memorable experiences...

Vaco by Highspring

Call Center Manager (100% Onsite; Kennesaw) Job at Vaco by Highspring

 ...Vaco Atlanta is working with an impressive client based in Kennesaw, GA looking for a dynamic Call Center Manager to join their team in a DIRECT HIRE position. This individual will be a key partner on the Call Center team to properly serve customers and fulfill the... 

Happy Tails Resort

Dog Groomer Job at Happy Tails Resort

 ...a professional, experienced groomer. Your approach to grooming dogs must be compassionate, patient and caring with attention to detail...  ...work on a team Company Description Happy Tails Resort is a daycare, grooming, and boarding facility. Company Description Happy... 

Provider Healthcare

Obstetrics & Gynecology Physician Assistant Job at Provider Healthcare

 ...Monday Thursday, 8:00 AM 6:00 PM Friday, 8:00 AM 12:00 PM hours per week Job Description: We re seeking an experienced OB/GYN PA for a locum assignment in Orlando, FL. You ll join a supportive OB/GYN department providing prenatal, postpartum, and some gynecological...