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

Block

Compensation Program Manager (San Francisco) Job at Block

 ...yours to Block. The Role We're looking for a Compensation Program Manager to manage and optimize intermediate to complex compensation...  ...best work of your career while building the life you want. Remote work, medical insurance, flexible time off, retirement savings... 

GC Associates USA

Cable Technician Job at GC Associates USA

 ...appliances. including: Install equipment, fiber, and copper cable for end Installation of ducts and conduits, pulling cables, and...  ...Install fiber optical transceivers. Install complete data center infrastructure (racks, PDU, CAT6, SM/MM Fiber, patch panels... 

Serena & Lily

Assistant Designer Job at Serena & Lily

 ...Assistant Designer, Textiles SAUSALITO, CA Serena & Lily is searching for an Assistant Designer to join our tight knit Design Team at our Sausalito Headquarters. Our ideal candidate has a strong work ethic, is eager to learn and brings to the table a technical skill... 

Acorns

Director of Communications Job at Acorns

 ...______________________________________________ Director of Communications | Acorns We're looking for an outstanding Director of Communications...  ...cash bonus awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility... 

SS Solutions

Sports-Minded Assistant Manager Job at SS Solutions

 ...Leadership and mentorship Entry-level management training Management and Leadership...  ...mentality to move up into a leadership role Sports-minded and Energetic team players...  ...Communications/Public Speaking Promotions/Events Why Us? We start all our assistant...