Job Title:聽Regulatory Affairs Specialist
Location:聽North Haven, CT
Duration:聽7+ months聽(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.