Regulatory Relations Specialist jobs in Fontana, CA

Required:

• Must have 3-5 years of experiences in Medical Device Regulatory Affairs

Skills:

• Have working knowledge in EU MDR
• Have working knowledge in Regulatory Change Assessment
• Have working knowledge in US and EU medical device submissions
• Have experience supporting internal and external inspections
• Work cross-functionally and in a matrixed environment
• Have experience with continuous improvement activities

Education: BA Degree Required

Duties:

• This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
• Assist the strategy implementation and operations for regulatory affairs activities, product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
• Identify opportunity for regulatory affair processes and drive changes to completion.

Job Type: Contract

Salary: $34.00 - $35.00 per hour

Expected hours: 40 per week

Benefits:

• Paid time off

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Regulatory affairs: 3 years (Required)
• EU MDR: 3 years (Required)
• Regulatory Change Assessment: 3 years (Required)
• medical device submissions: 3 years (Required)

Work Location: On the road