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Senior Clinical Affairs Specialist

Company Name: Zest Dental Solutions
Location: Carlsbad, CA
Job Type: Full Time
Contact Name: Debra Isaacs
Phone: 1-760-705-1123
Fax:
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary:

Job Description

The Senior Clinical Affairs Specialist will support the Regulatory Affairs department with all aspects of the Clinical function. 

  • Authoring Clinical Evaluation Reports in accordance with MEDDEV 2.7/1 rev 4.
  • Authoring Post Market Clinical Follow-up Reports, in accordance with MEDDEV 2.12/2 rev 2.
  • Conducting Post Market Surveillance, including protocols and reports, in accordance with EU requirements.
  • Assist the Regulatory Affairs Director and Manager with Clinical activities to ensure compliance with the new European Medical Device Regulations (MDR).
  • Ensure compliance with US and international regulations and guidelines.
  • Other duties as assigned


Job Requirements:

  • Senior Clinical Affairs professional with a degree from higher education in the respective field and 5 years of documented professional experience; or minimum 10 years documented professional experience.
  • Must have experience in the dental field with knowledge of the devices subject to evaluation. Must have knowledge in medical writing and research methodology, including clinical investigation design and biostatistics. 
  • Must have experience authoring Clinical Evaluation Reports in accordance with MEDDEV 2.7/1 rev 4; authoring Post Market Clinical Follow-up Reports, in accordance with MEDDEV 2.12/2 rev 2; conducting Post Market Surveillance, including protocols and reports, in accordance with EU requirements. Must be knowledgeable in MDR requirements.
  • Bachelor’s Degree in biology, chemistry, biochemistry, microbiology, or related discipline.
  • Experience with the use of spreadsheets, word-processing, and database application software (i.e. Excel, Adobe, Word).
  • Flexibility and agility to accommodate constant project changes and time constraints.
  • Ability to work in collaborative and independent work situations with minimal supervision.
  • Demonstrated interest and capability in learning subject matter and processes.
  • Demonstrated ability to solve problems with limited or no supervision.
  • Demonstrated effective interpersonal, teamwork, and communication skills required.
  • Ability to use Regulatory information systems.

To apply, please email resume to:  This email address is being protected from spambots. You need JavaScript enabled to view it.