Job Description

Role: Senior Regulatory Affairs Specialist

Location: Lake Forest, IL - 60045

Duration: 08 Months

Description:

Years Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs

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, including directing development of 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. "

Skills:

• Have working knowledge in EU MDR
• Have working knowledge in Regulatory Change Assessment in
• 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

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