Responsibilities:

Prepare, compile, and coordinate document packages for international regulatory submissions, license renewals, and annual registrations

Conduct regulatory assessments and manage change controls for high-risk implanted devices

Recommend changes for labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance

Monitor and improve regulatory tracking and control systems

Support internal audits, inspections, and interactions with regulatory agencies on defined matters

Stay current with regulatory procedures, guidelines, and requirements affecting international submissions

Recommend strategies to achieve earliest possible approvals of clinical trial applications and product submissions

Requirements:

Bachelor’s degree required

Minimum 4 years of experience in Regulatory Affairs

Experience with international submissions outside of US and EU for high-risk implanted medical devices

Experience in regulatory assessments and change controls for high-risk implanted devices

Familiarity with MDT systems

Preferred Skills:

Prior experience working with Medtronic or similar medical device companies

Knowledge of high-risk medical device regulatory pathways and approval strategies

Strong background in regulatory compliance for implanted medical devices

Pay Details: $49.00 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

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.