What are the responsibilities and job description for the Sr. Regulatory Affairs Specialist - Onsite position at Collabera?
Position Details:
Industry: Medical Devices
Job Title: Sr. Regulatory Affairs Specialist - Onsite
Location: Lake Forest, IL 60045
Duration: 08-12 months [ Possibilities of extension]
Pay Range: $65-$75/hr
Description:
We are seeking a Regulatory Affairs Specialist with 3-5 years of experience in Medical Device Regulatory Affairs.
The ideal candidate will have a strong working knowledge of EU MDR and Regulatory Change Assessment, as well as experience with US and EU medical device submissions.
This role will involve working cross-functionally in a matrixed environment to support internal and external inspections and drive continuous improvement activities.
Responsibilities:
Develop, update, and improve regulatory affairs processes in collaboration with multiple business units
Assist in the implementation of regulatory affairs strategies and operations
Direct the development of product registration submissions, progress reports, supplements, amendments, and periodic experience reports
Update and develop procedures to support changes in the regulatory landscape, including EU MDR
Identify opportunities for process improvements in regulatory affairs and drive changes to completion
Education Qualification:
Bachelor's degree in Life Science, Engineering, or a closely related discipline is required
At least 5 years of work experience in Quality or a related field; less experience may be considered with an advanced degree
Preferred experience in the Healthcare industry
Required Skills:
Proficiency in MS applications (Word, Excel)
Experience working in a Quality-related function
Ability to work effectively in cross-functional teams
Experience leading meetings and team discussions
Strong technical writing skills
Strong organizational skills and self-driven work ethic
Attention to detail and ability to resolve negotiations between team members
Salary : $65 - $75
