Regulatory Affairs Manager

Position Overview

The Regulatory Affairs Manager is responsible for independently managing regulatory affairs activities, originating appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements. This position is responsible for developing regulatory strategy, preparing regulatory submissions and obtaining regulatory approvals necessary to introduce new or re-designed products to market.

Essential Duties

include but are not limited to the following:

• Establishes regulatory strategy for product marketing.
• Plans, coordinates and compiles regulatory submissions with minimal review.
• Participates on project teams to provide appropriate information on regulatory issues and obtain information to meet regulation requirements.
• Acts as the Regulatory Affairs liaison with FDA and other regulatory bodies on behalf of the organization to facilitate timely and favorable review of submissions and issues.
• Maintains a current knowledge base on existing and emerging regulations, standards and guidance documents.
• Assists in reviewing new projects to determine the nature and scope of the regulatory involvement.
• Reviews labeling for compliance with regulations and assures that claims are substantiated.
• Supports organizational compliance with FDA and international regulations.
• Creates and maintains Regulatory Affairs SOPs.
• Highly organized and able to manage multiple projects and deadlines under strict timelines
• Strong interpersonal skills and verbal communication skills with the ability to listen, articulate and advocate
• Proven ability to lead and work effectively with and through multi-functional teams to achieve results.
• Strong leadership and communication skills.
• Strong decision-making skills.
• Ability to communicate ideas, opinions and counter arguments in a proactive and professional manner.
• Excellent oral and written communication skills.
• Strong attention to detail and recordkeeping skills.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to use computers daily in an interactive manner for extended periods of time.
• Ability to frequently and accurately communicate with employees in person, via the telephone or by email.
• Ability to travel domestically and internationally (< 10%).

• Master's degree in physical or life sciences and minimum three years of relevant experience; or a Bachelor's degree in physical or life sciences and 5+ years of relevant experience.
• 5 years' experience in the device or pharmaceutical industry.
• 3 years' experience in direct regulatory medical device submission with specific experience preparing 510(k), IDE and PMA submissions.
• 2+ years' experience in development, interpretation or application experience with standards, guidelines and special controls.
• Demonstrated experience with automated Quality System software such as Agile® PLM.
• Strong working knowledge and experience of FDA regulations and/or international registration requirements, with demonstrated success integrating regulatory content into projects.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

• 5+ years' experience in a regulated manufacturing environment, preferably in a GMP/QSR and/or ISO 13485 environment.
• Experience with Project Management principles and practice.
• Demonstrated experience in Six Sigma techniques.
• 1+ years' experience in international submission preparation.
• Supervisor experience is preferred.