This position is an integral member of both the Regulatory and Healthcare Compliance teams. The position reports to the Director of Regulatory Affairs for Regulatory Operations responsibilities, and directly to the VP Global Regulatory Affairs and Healthcare Compliance for Compliance responsibilities. As Regulatory Operations Manager, this position is responsible for establishing and maintaining Regulatory infrastructure, procedures, documentation, and records to optimize effectiveness and efficiency of the Regulatory function. Additional responsibility includes hands-on preparation and project management of global submissions. As Compliance Manager, this position is responsible for overall day-to-day implementation of the Gynesonics Healthcare Compliance Program, including establishment and maintenance of procedures, training, monitoring, and auditing.
Primary Responsibilities include:
Regulatory Operations Manager
· Develop procedures, tools, and infrastructure for effective and efficient regulatory operations, including management of product technical documentation; calendaring; tracking and renewals of annual licenses, registrations, and listing;
· Compile and organize documentation for use in submissions, notifications, and internal filings (“letter to file”). Maintain technical documentation files and authorized representative on-line repositories;
· Maintain regulatory calendar and correspondence files; track preparation and completion of required tasks including annual licenses, registrations, and listing.
· Enter information into regulatory databases, submissions software programs and/or AI regulatory intelligence and decision systems as available, and generation of reports as required;
· Assemble and submit product applications and notifications of change. Serve as submission project manager as needed;
· Review proposed claims, labeling, advertising and promotion materials to ensure regulatory compliance as needed;
· As needed, represents regulatory on development teams with internal stakeholders;
· Provide regulatory input and support for inspections and audits as needed;
· Monitor the regulatory environment, maintain information resources, and disseminate changes/updates, as needed;
· Other duties as assigned.
· Identify opportunities for, develop, and implement improvements to the Healthcare Compliance Program and its implementation;
· Develop, implement, and deliver the Gynesonics health care compliance training program including knowledge assessments, in self-training and/or in-person formats;
· Develop and implement monitoring plan and reports to ensure compliance with policies and procedures. Propose recommendations for corrective actions;
· Assist in preparation, conduct, and reporting of health care compliance audits;
· Manage systems to log and track documentation, approval, and expiry of Business Need Justifications, HCP contractual engagements, sponsorships, grants, and other activities related to implementation of the healthcare compliance program;
· Review advertising and promotion materials and activities to ensure compliance with healthcare compliance policies;
· Assist in preparation for and facilitation of Health Care Compliance Committee meetings and activities;
· Assist in identification of compliance risks and facilitation of development and management of annual compliance workplan;
· Other duties as assigned.
Education Level, Required Skills and Experience:
o Bachelor degree in engineering or life science required.
o 6+ years medical device regulatory affairs experience.
o Prior experience personally writing and managing OUS submissions using formats such as ASEAN CSDT, Canada TOC, and EU MDR.
o Direct experience working with in-country regulatory partners.
o Direct experience with audit preparation and conduct.
o Experience with regulatory databases, submissions software programs and/or AI regulatory intelligence and decision systems strongly preferred.
· Strong practical understanding of Healthcare Compliance programs and policies as related to the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and applicable regulations such as Anti-Kickback, False Claims, Foreign Corrupt Practices Act, and transparency reporting regulations.
· Strong understanding of ISO 14971, ISO 13485, 21 CFR 820, and EU MDR
At Gynesonics, our mission is to advance women's health by developing transcervical, uterus-preserving, incisionless technologies for diagnostic and therapeutic applications.
We are committed to providing women with a safe and effective incisionless alternative to the invasive surgical techniques of hysterectomy or myomectomy for their symptomatic uterine fibroids