Job details
Salary $35 - $45 an hour job type full-time contract number of hires for this role 1
Qualifications
Bachelor`s (required)
Full job description
Local candidates in san diego preferredWill consider strong remote candidates.
Quality systems specialist/regulatory specialist who will performs coordination and preparation of document packages for regulatory submissions as well as compile all materials required in submissions, license renewal and annual registrationsStrong qms
Quality system:
Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
Leads resolution of audit and inspection findings.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company`s mission globally.
Regulatory:
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
Qualifications:
Requires a university degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Equal opportunity employer/veterans/disabled
To read our candidate privacy information statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/
The company will consider qualified applicants with arrest and conviction
Job types: full-time, contract
Pay: $35.00 - $45.00 per hour
Benefits:
401(k)
Dental insurance
Health insurance
Life insurance
Referral program
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to friday
Education:
Bachelor`s (required)
Experience:
Medical device: 2 years (required)
Regulatory affairs/quality system: 2 years (required)
Work location: one location
