Regulatory Affairs Specialist I - Merrimack, NH in Merrimack, NH at Getinge

Date Posted: 7/30/2019

Job Snapshot

  • Employee Type:
  • Location:
    Merrimack, NH
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Job Function Summary:

Responsible for internal, domestic and international compliance activities working under the direction of the Sr. Manager Regulatory Affairs.

Position Responsibilities:

  • Collects information and documentation for routine submissions to regulatory agencies.
  • Seeks out related documentation as required to request agency approvals or in response to agency requests.
  • Update basic information provided to various departments regarding submission requirements and standards to facilitate efficient processing by agency.
  • Compiles and logs submissions that need review to ensure they meet regulatory submission standard policies, and operating procedure requirements.
  • Gathers regulatory submissions to be reviewed for compliance and submission standards.
  • Tracks through review process to ensure timely submission.
  • Maintains effective relationships with internal customers.
  • Support with Field Correction and Recall activities.
  • Participates in the review and disposition of labeling, promotional material and product modifications.
  • Prepares documentation and coordinates activities related to PMA's, 510k's, and IDE's.
  • Supports engineering changes through RA/QA practices by documenting the changes in compliance
    with the Quality Systems Regulations, the Medical Device Directives, CMDR, and other International regulations.
  • Participates in cross-functional departmental team projects and product development activities/meetings.
  • Assists in special projects as needed.

Required Knowledge, Skills and Abilities: 

  • 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.
  • Able to produce high-quality work with a high level of attention to detail.

Minimum Requirements:

  • Bachelor's Degree in Scientific/Engineering discipline or equivalent work experience in a regulated industry.
  • Good working knowledge of MS Office (Word, Excel, Outlook).

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.