IntePros is seeking a Sr Regulatory Affairs Specialist to join their team in a remote capacity. The role involves managing regulatory submissions and ensuring compliance for medical device products.
About the Role
As a Sr Regulatory Affairs Specialist, you will prepare and submit regulatory documents, support internal regulatory processes, collaborate with cross-functional teams, and ensure adherence to FDA, ISO, and other regulatory requirements.
About You
Required:
Previous experience working in a medical device company.
Hands-on experience with regulatory submissions (FDA, 510k, CE, or equivalent).
Strong knowledge of internal regulatory processes.
Excellent written and verbal communication skills.
Ability to work independently in a remote environment.
Detail-oriented with strong organizational skills.
Benefits
Competitive hourly rate of $60.00/hr - $80.00/hr.
Potential for extension or conversion to full-time after 12 months.
IntePros
IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
Company Size: 201-500 employeesIT Services and IT Consulting