Zest Anchors (Zest Dental Solutions)
2875 Loker Ave. East
Carlsbad, CA 92010
Senior Clinical Affairs Specialist
General 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.
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.
Application Information & Contact (How to Apply)
To apply, please email resume to: Debra.Isaacs@zestdent.com
Learn more about Zest Anchors here