Purpose

The Regulatory Affairs Manager is responsible for supporting and managing the regulatory affairs TigerBioscience Global Regulatory Department and functions to ensure regulatory compliance of quality management system, product realization and marketing authorization.

Responsibilities

• Facilitate accurate and timely approval of submissions by ensuring compliance with FDA and
• Health Canada regulations and interpretations of Class II devices.
• Interact with regulatory agency personnel in order to expedite approval of applications, and responses to questions.
• Partner with Product Development, Marketing and other cross functional groups to compile appropriate technical information for supporting various regulatory submissions
• Support Marketing Material Development and Compliance to federal regulations, including website development, printable material, and speaking engagements.
• Manage unique device identifiers (UDI) submissions.
• Manage and lead regulatory submissions for Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, International Registrations etc.
• Managing regulatory compliance, evaluating regulatory issues and providing accurate and timely recommendations and alternatives, as needed, to management and functional business units.
• Serves as a team leader on the development and submission of 510ks and PMA applications Evaluate changes to regulatory documents, updates, FDA requests and formulates strategies to maintain submission goals Support and Collaborate with Product Commercialization RA team.
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
• Participate in FDA and other regulatory agency inspections.
• Review and approve proposed design and/or labeling changes to ensure international and domestic regulatory compliance.
• File and maintain records in accordance with standard operating procedures.
• Attend/participate in offsite business meetings/conferences.
• Perform other related duties as assigned.
• Support cross functional Regulatory Affairs tasks when needed
• Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.
• Work overtime during weekdays and on the weekend as needed to support business/operational needs.
• Perform other related duties as assigned.

Skills

• Thorough knowledge of all FDA requirements pertaining to the control and submission of regulatory documents for medical device approval.
• Excellent organization skills and the ability to multi-task; detail oriented.
• The ability to establish and maintain good working relationships at all levels of the company and with external contacts.
• Excellent verbal and written communication skills. Share concepts, ideas, information, and suggestions with management, peers and others.
• The ability to evaluate regulatory documents and determine appropriate action.
• The ability to provide regulatory assessment to other departments with little or no supervision.
• Excellent attention to detail and organizational skills.
• Ability to multi-task.
• Effective and verbal communication skills.
• Strong Leadership skills.

Qualifications/Requirements

• Bachelor’s degree from an accredited college or university required in a biological science or related field required.
• Master’s degree from an accredited college or university preferred.
• At least 5 years of quality and/or regulatory experience in an FDA/MDR regulated environment for medical devices (or related field) with progressive management responsibilities/experience.
• Clearance of favorable background investigation required.