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

VETERANS HEALTH ADMINISTRATION

Chiropractor Job at VETERANS HEALTH ADMINISTRATION

 ...Summary The staff chiropractor provides treatment and care of spine-related neuro-musculoskeletal conditions to eligible beneficiaries. The staff chiropractor utilizes chiropractic manipulation - also called chiropractic adjustment to restore joint and related soft... 

Gap

Store Leader: Inspire Teams, Drive Growth & Experience (Torrance) Job at Gap

A leading retail brand is seeking a store leader in Torrance, California. In this role, you will set the tone for the store team, ensuring exceptional customer experiences through leadership and coaching. Your responsibilities include recruiting top talent, driving performance...

FocusGroupPanel

Remote Data Entry Clerk Flexible, Part-Time, Entry-Level Job at FocusGroupPanel

 ...A remote work company is seeking a Data Entry Clerk to work from home. This entry-level position offers flexible hours and is suitable for individuals from various backgrounds. Responsibilities include performing data entry tasks while following specific guidelines. No... 

Petro 49, Inc.

CDL Truck Driver Fuel Delivery, Ketchikan Job at Petro 49, Inc.

 ...deliveries of products to customers via fuel truck as assigned by the Terminal Manager...  ...to wear a company provided uniform. Drivers should dress for the current outdoor conditions...  ...Card, Hazmat endorsements. Must carry a Transportation Worker Identification Card and pass... 

INTEGRIS Health

Physician Assistant - Interventional Radiology - Southwest Med Ctr Job at INTEGRIS Health

 ...Job Description Join our dynamic Interventional Radiology team at INTEGRIS Health Southwest Medical Center, where every day brings...  ...opportunities to make a meaningful impact. As a full-time Physician Assistant, you'll work under the supervision of a radiologist to provide...