25 Jan
Quality and Regulatory Specialist
Minnesota, Saintlouispark , 55426 Saintlouispark USA

Vacancy expired!

This Jobot Job is hosted by: Allison PatiernoAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.

A bit about us:Our client uses an innovative, virtual process to keep our service quality of the highest caliber and our timelines and costs as low as possible. The team is a dynamic partner; running clinical trials, negotiating with regulatory authorities, building quality systems and providing biomedical engineering solutions. Our client is a face paced and fast changing workplace where they are able to help both Fortune 500 and visionary start-ups with their Clinical, Regulatory, Quality and Engineering needs. They are dedicated to working together on some of the most difficult problems while managing the day to day details in an efficient and professional manner.

Why join us?Competitive salaryBenefits; medical, vision, dental401k with employer match

Job DetailsTo complete Clinical, Regulatory, Quality and Engineering (CRQE) projects for pre-and post-market products while ensuring consistency with regulations, quality standards, commitments and goals.Responsibilities:
  • Manage individual projects collaboratively with team on behalf of clients to keep projects on time, high quality and within budgets
  • Critically assess and complete project requirements which may include:
clinical research studies/clinical evaluation reports (CER) regulatory submissions quality management systems to engineering reports
  • Improve quality by suggesting improvements, training and carefully following internal and external SOPs, Work Instructions and Forms/Templates for successful preparation of robust, high quality deliverables
  • Critically assess and follow regulations, standards and guidance documents (e.g. FDA, EU) relevant to client projects across multiple industries and disciplines
  • Develop materials for on-line and in-person training (e.g. PowerPoint presentations)
  • Evaluate and complete literature searches and communicate scientific content in a clear, concise manner
Qualifications:
  • Master's Degree or PhD in a medical or science-related field or equivalent work experience
  • At least 5 years clinical, regulatory, quality and/or engineering work experience
  • Demonstrate ability to actively manage and complete projects
  • Advanced computer skills with Outlook, Word, Excel, PowerPoint and other software tools
Requirements:
  • Must be focused, efficient, detail oriented and able to work independently
  • Able to travel to client sites as needed (approximately 10% travel)
  • Demonstrated ability to execute projects on time and on budget
  • Must have excellent critical thinking and problem-solving skills
  • Able to coordinate and conduct training sessions and to secure required training documentation
  • Able to reprioritize immediately as new projects arrive
  • Passion for clinical research, regulatory, quality and engineering affairs activities for pharmaceutical, medical device and food industries
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

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