Regulatory Affairs Specialist (EU Submission) RM26

Job Title: Senior Regulatory Affairs Specialist
Location (On-site, Remote, or Hybrid?): Santa Clara, CA (Onsite)
Contract Duration: until 10/25/2027
Working hours: 8 am - 5 pm 
 

Description:

Exempt/Non Exempt: Non Exempt

Years Experience:

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 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

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, 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.