Medical Device, Quality/Risk Management, Regulatory Compliance, Submission & Registration
Summary of Major Responsibilities
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 and Responsibilities
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 time lines.
Strong interpersonal skills and verbal communication skills with the ability to listen, articulate and advocate.
Education and Experience
Master’s degree in physical or life sciences and minimum 3 years of relevant experience; Bachelor’s degree in physical or life sciences and minimum 5 years of relevant experience; Associate’s degree in physical or life sciences and minimum of 6 years of relevant experience; or a high school diploma and a minimum of 9 years of relevant career experience in lieu of degree.
Demonstrated experience with automated Quality System software such as Agile®.
Proven ability to lead and work effectively with and through multi-functional teams to achieve results.
Strong working knowledge and experience of FDA regulations and/or international registration requirements, with demonstrated success integrating regulatory content into projects.
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.
5+ years of device or pharmaceutical industry experience.
3+ years of direct regulatory medical device submission experience with specific experience preparing 510(k), IDE and PMA submissions.
2+ years of development, interpretation or application experience with standards, guidelines and special controls.
5+ years of 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 of international submission preparation experience.
Supervisor experience is preferred.
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%).
Internal Number: 2019-3271
About Exact Sciences
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