Sr. Analyst, Field Assurance (Temporary)

Location

Aliso Viejo, California, USA

Department Name

525-Field Assurance

Qualifications

1. Bachelor’s degree or equivalent combination of relevant experience, education and training.
2. Minimum of five (5) years complaint handling/post-market surveillance experience with Class II/III vascular intervention, surgical/implantable, or neurological interventional medical devices.
3. Knowledge of FDA 21 CFR part 803/820, ISO 13485:2016, Vigilance (MEDDEV), and Canadian adverse event reporting regulations for Class II/III medical devices.
4. Strong analytical and critical thinking skills with the ability to make sound judgments based on objective data and acquired knowledge.
5. Excellent writing/composition skills with the ability to construct clear and comprehensive clinical/technical narratives.
6. Excellent verbal communication skills, with demonstrated success in establishing and maintaining effective interpersonal relationships.
7. Excellent time management skills with the proven ability to prioritize daily conflicting demands to meet strict regulatory compliance and organizational deadlines.
8. Excellent cross-functional team collaborative skills.

1. Experience working in a clinical/healthcare setting (endovascular, cardiovascular, critical/surgical care) or related medical device environment.
2. Experience with preparing and submitting MDRs/eMDRs for Class II/III devices.

External-Facing Title

Sr. Analyst, Field Assurance

Posting Country

US - United States

Salary Range

$40.00/Hour - $53.00/Hour