What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at Collabera?
To discuss more about this job opportunity, please reach out to Himanshu Kumar Singh(LinkedIn URL - https://www.linkedin.com/in/himanshu-kumar-singh-57b782258/), email your updated resume at Email - himanshu.ksingh@collabera.com or give me a call at (425) 403-0902. Thank you!
Pay Range: $65 - $72/hour
Position Details:
- Industry: Medical Device
- Job Title: Senior Regulatory Affairs Specialist
- Duration: 8 months(possible extension)
Job Description:
- The Senior Regulatory Affairs Specialist will be responsible for coordination of Performance Evaluation documentation updates within a cross-functional team of reviewers.
- They will lead discussions to revise and finalize document updates, as well as drive document approvals in the quality system. They will ensure documentation adheres to current quality procedures and templates.
Education/Experience min.
- Apprenticeship or bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
- At least 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
- Preferred experience in the Healthcare industry.
Top 5 skills/requirements HM would like to see on resume:
- MS application proficiency (Word, Excel)
- Experience working in a Quality-related function
- Experience with cross-functional teams
- Experience leading meetings and team discussions
- Experience with technical writing
*Skillset from previous person: The previous employee had strong organizational skills and was self-driven to follow-up on outstanding items to complete tasks. Not having attention to detail and ability to resolve negotiations between team members would make this position a challenge for the next person.
Salary : $65 - $72
