Regulatory Affairs Specialist

St Paul, MN

Posted: 02/21/2024 Industry: Scientific Job Number: 24-00089

Job Description


The Regulatory Affairs Specialist is responsible for working as part of project teams with product development and manufacturing management to ensure that the product development process meets all applicable regulatory requirements. Responsible for the approval of labeling, marketing literature and finished good specifications.

Responsibilities
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Utilize this understanding to develop clear procedures for the organization.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Act as a liaison between their organization and state, local, federal, and international agencies. Including communicate on pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Participate as a member of project teams to ensure Design Control, Risk Management, and Release to Market activities are in compliance with appropriate standards/regulations
  • Coordinate, prepare and review documentation for international and domestic submissions for to FDA, Health Canada and other international regulatory agencies.
  • Strategically achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, technology, compliance, and costs.
  • Responsible for supporting project teams on various subjects, including export and labeling requirements, premarket regulatory requirements, and clinical study compliance issues.
  • Review labeling, and finished good specifications, as well as, marketing literature.
  • Assist on special projects and perform additional duties as assigned

Qualifications
  • Bachelor's degree in science or a related field
  • 3+ years'experience within Regulatory Affairs
  • Ability to work on project teams.
  • Strong communication, organizational and time management skills. Technical writing skills.
  • Proficient in Microsoft Office
  • Experience with RIMS (Regulatory Information Management Systems) - preferred
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

Meet Your Recruiter

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.