Job Title: Project Manager, Regulatory Affairs

Supervisor/Manager Title: Senior Manager, Regulatory Affairs

Job Description Summary: Responsible for timely preparation and submission of organized, scientifically valid global regulatory affairs submissions (clinical, pre-, and post-market applications), query responses and correspondence tracking.  Maintains regulatory information for competitive intelligence, literature maintenance, and standards review programs. Interacts with internal departments and external representatives (i.e., distributors, legal agents, regulatory agencies). Provides expertise in translating regulatory requirements into practical, workable strategy and planning documents. Provides counsel to project team members and regulatory affairs staff as applicable.  Supports serious adverse event reporting, and completion of post-market surveillance activities (complaints, MDR and vigilance reports). Performs other projects and duties as assigned.

Job Responsibilities:

• Prepare timely, high-quality, technical documentation and regulatory submissions for investigational device applications, commercial registrations, annual reports, and amendments/supplements.


• Serve as a regulatory team member of product development and sustaining teams, providing clear, concise regulatory strategy to ensure applicable global requirements are met for product development and quality system projects.  


• Collaborate with key stakeholders to develop technical, clinical, or labeling content (including Clinical Operations, Marketing, R&D, Manufacturing and Quality) to support company objectives and regulatory submissions.


• Provide coaching and support to other members of the regulatory department.


• Communicate with regulatory bodies, legal agents, distributor partners, and suppliers on project-related activities necessary to ensure appropriate regulatory approvals are in place in covered regions.


• Review document change orders for impact on US, EU and international regulatory filings per standard procedures.


• Manage standards review process and assist company SME’s to interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects, clinical studies, testing, and record keeping.


• Support serious adverse event reporting process, Medical Device Reports (MDRs), Vigilance reports, field safety notices, and other communication with regulatory authorities and external stakeholders. 


• Review and approve FMEAs/risk analyses, protocols, reports, NCRs, CAPAs, and other technical documents.


• Participate in internal audits and external audits as needed. 


• Update and maintain departmental procedures as required.


• Perform other duties as assigned.