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Sr. Specialist Regulatory Affairs

Company Name: Tenex Health
Location: Lake Forest, CA
Job Type:
Contact Name: Bob Mitchell
Phone: 714-329-2018
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: 75k - 105k depends on experience

Job Description

Position serves in the traditional role of a Sr. RA Specialist in the area of medical device
design and development support as well as acts in the capacity at times, of a Quality Engineer.

Additional significant roles include that of managing the CAPA Subsystem , the Lead Auditor
and Manager of the Internal Audits Subsystems, performs .Will have an appropriate
background in microbiology and serve as the Company expert in sterilization and
biocompatibility. Background in document control is a plus.

Ability to advise the design team in the area of elect rical testing and certification and
appropriate standards is a plus

Job Requirements

Participate in design teams as the RA Expert and Quality Engineer.
Manage the Company's CAPA and Interna l Audits Subsystems .
Plan and schedule internal audits.
Oversee Corrective and Preventive Action from initiation to closure.
Serve as a backup to filing MDR's.
Expert knowledge and experience in sterilization and product certification standards is
Maintain design control and technical files, DFMEA, PFMEA, Risk Assessment, and facilitate
Health Hazard Evaluations.
Experience in facilitating FDA QUSIT's and IS013485 audits.