Sr. International Regulatory Affairs Specialist Job at Custom Search Inc., Minneapolis, MN

WnZ6MkZUYkx6cFVmWjFacDMyK2ZLeHo1dXc9PQ==
  • Custom Search Inc.
  • Minneapolis, MN

Job Description

Our mid-sized medical client is adding a Sr. Regulatory Affairs Specialist to their team! The Sr. Regulatory Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Sr. Regulatory Affairs Specialist will perform regulatory submission/approval activities for all products and ensures compliance with required regulations and established corporate standards.

Your role with the company:

  • Preparing documentation for international regulatory registrations
  • Preparing technical documentation compliant with regulations
  • Defining worldwide regulatory requirements necessary for regulatory approval of products
  • Participating on cross-functional teams as regulatory lead
  • Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages
  • Authoring submissions, researching requirements, setting priorities, and maintaining project schedules
  • Providing guidance and oversight to team members related to regulatory compliance
  • Act as a Subject Matter Expert (SME) to support internal and external audits

Desired Profile:

  • Bachelor’s Degree in Science, Engineering, or other relevant discipline
  • Minimum 8 years’ experience in Regulatory Affairs in the medical device industry
  • FDA, EU, Health Canada, and international registrations experience
  • Working knowledge of quality system regulations and guidelines
  • Ability to develop clear, concise, and timely oral and written reports
  • Great communication skills with all levels of personnel
  • High level of organization and planning skills
  • Working knowledge of medical devices, procedures, and terminology

Job Tags

Remote job, Worldwide,

Similar Jobs

Crime Scene Resources, Inc

Digital Forensics Investigator Job at Crime Scene Resources, Inc

 ...investigations including deploying into the field to assist Law Enforcement in evidence searches and collection. Conduct on-site forensic analysis previews of digital evidence. Prepare detailed reports of digital evidence extractions, analyses, and investigations.... 

National Health Partners

Hospitalist Opportunity - Orlando, Florida Job at National Health Partners

 ...hospital. This is hybrid model where you see a few patients in the office in the afternoon. Start your day at 7 am. Four day work week!...  ...rounding, admitting and discharging then in the afternoon go back to the office and see 7 to 10 patients. Sometimes finishe work by... 

Planet Group

Remote Medical Writer Job at Planet Group

 ...picture thinking with problem solving skills University degree with minimum two years experience. Masters level preferred Medical Writer for EU MDR. Writes and edits documents for EU MDR clinical and post-market surveillance documents (CEP, SSCP, PSUR),or scientific... 

University of Pennsylvania

CIS Lecturer Positions 2025 Job at University of Pennsylvania

 ...CIS Lecturer Positions 2025 Location: Philadelphia, PA Open Date: Oct 08, 2024 Deadline: The University of Pennsylvania's Department of Computer & Information Science is pleased to welcome applications for multiple teaching positions as a Lecturer or Senior... 

ASI

Commercial Roofer Job at ASI

 ...ASI Commercial Roofing & Maintenance is central Ohios premier employee-owned roofing company. Whether you are looking for a new career, or a seasoned trade professional, we want to meet you! We are growing rapidly, and looking for full-time, year round Service Technicians...