To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Job Description:
Job Roles & Responsibilities:

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. 

Manager Comments:

• Prior Regulatory submission experience. 
• Cardiovascular medical device experience required. 
• Reviewing Change Assessment.
• Regulatory Submission.
• Responsible for doing international work for regulatory affairs.
• Having submission writing experience and reviewing submission documents and reviewing protocols and reports
• Assess manufacturing changes