Regulatory Affairs Specialist

Job Summary

To support regulatory compliance efforts, the contract Regulatory Affairs Specialist will manage regulatory submissions, provide guidance on global regulatory strategies, and represent the regulatory function within product development teams.

Key Responsibilities

• Create and track regulatory submissions while ensuring alignment with global operating plans
• Provide guidance on OUS regulatory requirements and propose strategies for expediting approvals
• Represent the regulatory function in cross-functional teams, addressing regulatory requirements and conflicts during product development

Required Qualifications

• Bachelor's Degree or equivalent in a scientific discipline (e.g., Biology, Microbiology, Chemistry)
• 5-7 years of experience in regulatory affairs, particularly with medical devices
• Solid knowledge of global regulations relevant to Class II and/or Class III devices
• Proven expertise in Microsoft Office Suite, including Word, PowerPoint, and Excel
• Experience with new product development systems and regulatory registration processes