Regulatory Affairs Project Manager - Medical Dev – Fremont

Responsibilities:

The Regulatory Affaors Project Manager will be responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process within Boston Scientific's Neurovascular Division.

Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.

Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.

Develops and implements regulatory strategies for new and modified products.

Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.

Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.

Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.

Develops and implements departmental and divisional policies and procedures.

Supports highly technical or major business segment product lines, special projects or strategic initiatives

Requirements:

Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline. Professional certification(s) preferred. 8 plus years Regulatory Affairs medical industry experience.

Demonstrated success in management of regulatory submissions activities. Thorough understanding of global regulations. Strong technical knowledge of medical products. Strong technical understanding of relevant procedures, practices, and associated medical terminology. Strong knowledge of clinical trial strategy and study design, and sponsor reporting requirements. Thorough knowledge of product development process and design control. Excellent research and analytical skills.

Ability to manage multiple projects.

Excellent written and oral communication, technical writing and editing skills.

Strong leadership, interpersonal and influencing skills. Proficiency with Microsoft Office.

Apply Here