Regulatory Manager

Open Scientific provides contract staffing and direct hire recruitment services for the scientific, engineering, laboratory and manufacturing sectors.

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.