Senior Clinical Affairs Specialist

Company Name:

Zest Anchors (Zest Dental Solutions)

Job Location:

2875 Loker Ave. East

Carlsbad, CA 92010

Position Title:

Senior Clinical Affairs Specialist

Position Type:

Full-time

General Job Description:

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

Responsibilities:

  • 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.

Qualifications:

  • 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