Regulatory Affairs Specialist

Regulatory Affairs Specialist responsible for reviewing and assessing changes to Class II medical devices, supporting global regulatory compliance, and collaborating with cross-functional teams.

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Job Requirements:

• University degree with a minimum of 4 years of relevant experience

• 2�5 years of experience reviewing changes and determining regulatory impact for Class II medical devices

• Strong understanding of change control for commercialized medical products

• Experience completing regulatory assessments for U.S. and EU geographies

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Preferred Skills:

• Effective communicator with ability to work cross-functionally

• Experience collaborating with regulatory staff across multiple regions

• Familiarity with supplier, design, labeling, and manufacturing change documentation

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Job Responsibilities:

• Review design, labeling, supplier, and manufacturing changes for Class II medical devices

• Perform regulatory impact assessments for both U.S. and EU markets

• Represent the Regulatory function in cross-functional project and change control teams

• Coordinate with regional regulatory staff to ensure comprehensive global assessments

• Maintain compliance with regulatory requirements and document regulatory rationale for changes

Pay Details: $40.00 to $60.00 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 Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance