Regulatory Manager

Position Summary

Manages the regulatory side of the company business to ensure timely product approvals and compliance with domestic and international regulatory requirements

Key Accountabilities:

· Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA Annual Progress Reports, 510(k)s, MAFs)

· Develop Design Dossiers and Technical Files for CE marking purposes

· Develop other international regulatory submissions as required

· Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.

· Review, edit and provide regulatory and quality system approval for project documentation.

· Review and analyze technical protocols, data, and reports generated by Research and Development, Operations, Clinical Research, Quality Assurance or other related departments.

· Participate in the development of world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.

· Partner with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities.

· Develop procedures to ensure regulatory compliance

· Act as an active regulatory representative on project teams

· Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.

· Review and provide regulatory authorization for Nonconformance reports (NCR)

· Provide Regulatory Affairs support during internal and external audits.

· Prepare and file facility registration documents

· Conduct external audit activities as requested

· Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA

· Manage commercial device tracking

· Develop clinical protocols and clinical study reports

· Prepare and submit medical device reports

· Perform various other duties as assigned

Internal Networking/Key relationships:

This position requires cooperating with different company departments, such as R&D, Sales, Logistics, Finance and the other team members of the department.

Minimum Skills and Capabilities:

· Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team.

· Excellent written, verbal communication and presentation skills are required.

· Excellent attention to detail and ability to coordinate multiple activities simultaneously

· Excellent computer skills including expertise in Microsoft Office Products, in addition to, Lotus Notes.

Minimum Knowledge & Experience required for the position:

· Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required. Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or biomedical area).

· Solid knowledge of US and European regulatory processes, including Class III is required.

· Practical (hands-on) experience in a medical device regulatory environment, preparing submissions (IDEs/IDE supplements, PMAs/PMA Supplements, 510(k)s and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record is required.

· Experience interacting with U.S. FDA and European Notified Bodies is required.

· Experience presenting at FDA meetings is preferred.

· Sound knowledge and understanding of how IDE-regulated clinical studies are performed is required.

· Experience in review and approval of promotional review process strongly preferred

· Comprehensive Knowledge of Design Control processes and controls

· Comprehensive Knowledge of Regulatory Standards needed in the medical device environment.

Travel requirements: Minimal

All your information will be kept confidential according to EEO guidelines.