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

King Delivery Service Inc

Delivery Driver Helper- King Delivery LLC Job at King Delivery Service Inc

 ...delight hundreds of customers every day? Apply to be a Delivery Driver Helper today. We offer competitive compensation, benefits, a great...  ...responsibilities include: Loading and unloading packages (up to x-x packages per day) Handling large and bulky items using... 

Vohra Wound Physicians - Atlanta, GA - Vohra Wound Physician...

Internal Medicine - Physician Job at Vohra Wound Physicians - Atlanta, GA - Vohra Wound Physician...

 ...Full time work: Monday - Friday (7am-4pm) or part time available. No call / No weekend clinical responsibilities. Physicians...  ...wound care fellowship W2 employment contract (No work visa sponsorship is available) Benefits: Full health and... 

Lancesoft INC

CRNA - Anesthesiology job available in Rochester, Michigan Job at Lancesoft INC

 ...(AANA) Required Active MI License Required Clean Background Required BLS and ACLS Required PALS Preferred...  ...Mileage Reimbursement: Included No reimbursement for background checks, credentialing, or Med Staff fees This is an excellent... 

Comparion Insurance Agency

Insurance Agent Job at Comparion Insurance Agency

 ...Comparion Description Comparion Insurance Agency is hiring self-...  ...benefits from day one, including health insurance, generous 401(k) match...  ...time off. Paid training, licensing support, and ongoing development...  ...Liberty Mutual exclusive agents to an agency that delivers a... 

SHERIF A FARAG MD PC

Medical Assistant Job at SHERIF A FARAG MD PC

 ...Opportunities Job Summary We are seeking a GI Endoscopy Medical Assistant to join our team! As a Medical Assistant, your...  ...equipment, and cleaning instruments and rooms as needed. No experience needed but preferred. Qualifications BLS Certification...