Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Location: North Haven, CT
Duration: 7+ months (Possibility of extension)

Job Roles & Responsibilities

• Compiles all materials required in submissions, license renewal, and annual registration.
• Technical file remediation, DHF experience, Microsoft project experience a plus as we need to build regulatory plans in Gantt.
• Assist in submission preparation (e.g. 510ks, Change Notices to Notified Bodies). Overall knowledge of regulatory documentation.