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

Printfly Corporation

Social Media Manager Job at Printfly Corporation

 ...yes mentality, collaboration, and bold, creative thinking. About the Role Were looking for a creative, trend-savvy Social Media Manager to join our expanding, award-winning Social Media Marketing Team. As leaders in the custom apparel and printing industries... 

C&S Wholesale Grocers

Warehouse Order Selector - Full Time 2nd Shift Job at C&S Wholesale Grocers

 ...from our distribution centers to our offices every employee of C&S and their family of companies works to help feed local families, neighbors and communities. As a Warehouse Selector, youll pick, gather, and organize product and prepare orders for delivery to local... 

Drummond Woodsum

Municipal Attorney Job at Drummond Woodsum

 ...inquiries are held in the strictest of confidence. Drummond Woodsum is a full-service law firm with more than 100 attorneys and consultants providing a wide range of services for our clients, which range from some of the nations largest corporations to small start-up... 

OXYENERGY

Digital Marketing Intern Job at OXYENERGY

 ...Job Description About the Role: Join OXYENERGY as a Digital Marketing Intern and gain hands-on experience across social media, influencer marketing, and content strategy in the dynamic wellness industry. Youll work closely with our marketing team to support day... 

Cardinal Health

Delivery Driver - Pharmacy Services Job at Cardinal Health

 ...What Pharmacy Services & Delivery contributes to Cardinal Health Pharmacy Operations is responsible for the safe, efficient and effective coordination of Cardinal Health's pharmacy operations that service acute care hospitals, hospital retail customers, ambulatory...