Sr. Regulatory Affairs Specialist - Medical Device
Location : remote
Contract : 9 Months + potential for extension or permanent Conversion
Benefits : Real Staffing offers medical, dental, vision, 401K
W2 Employment Opportunities - Unable to offer sponsorship*
HM's Top Needs :
- US and EU regulatory requirements for product modifications
- IDE and PMA Annual Reports, IDE Supplement, PMA Supplement
- MDD and MDR STED updates
Education Required : Bachelors Degree
- Provide strategic input and technical guidance on regulatory requirements for product modifications
- IDE and PMA Annual Reports, IDE Supplement, PMA Supplement, MDD and MDR STED updates and EU MDR submissions.
- Manage multiple projects and prioritize tasks to meet project schedules
- Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities
- Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
- Participate in internal and external audits as needed
Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
EOE Statement : Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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