Summary:
Ensure compliance with US and EU regulatory requirements while supporting regulatory submissions in collaboration with the international regulatory affairs group.

Job Requirements:

Experience with regulatory requirements for product modifications

Knowledge of IDE and PMA Annual Reports, IDE Supplements, PMA Supplements, MDD and MDR STED updates, and EU MDR submissions

Ability to manage multiple projects and prioritize tasks to meet project schedules

Experience interfacing with engineering, quality, clinical, marketing, and other departments

Preferred Skills:

Familiarity with developing and revising departmental procedures to improve operations or reflect changing regulatory requirements

Job Responsibilities:

Provide strategic input and technical guidance on regulatory requirements for product modifications

Manage regulatory documentation and submissions, including IDE and PMA reports and EU MDR submissions

Oversee multiple projects to ensure compliance with regulatory timelines and requirements

Collaborate with internal departments to support regulatory affairs initiatives

Develop and update departmental procedures to align with evolving regulatory standards

Pay: 45-66

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $45.00 to $66.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance