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Job Information
Job title

Regulatory Affairs Project Manager

Company Boston Scientific
Wage Not specified
Location United States, California, Fremont
Employment type Full Time
Education Not Specified
Year Experience 3 - 4 Years of Practical Experience
Travel About 25%
Published on 1/7/2005
Description
Responsibilities:

Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process. Prepares complex submissions to gain approvals for clinical research, export, and commercial distribution for device and drug/device combination products such as: IDE, IDES, IDE Progress Report, Clinical Trial Submission [OUS], 510(k), PMA, PMAS, PMA Annual Report, HUD Designation, HDE, Shonin, PLA, CE-Mark Design Dossier, CE-Mark Technical File, Intercontinental Dossier. Ensures that existing approvals and documentation are maintained. Communicates with in-country BSC RA personnel to facilitate global clearances/approval.

Provides input on and reviews Design Control documentation such as: Risk Management, design verification, design validation, shelf life studies, pre-clinical studies, and clinical studies. Using knowledge of the following, guides team activities to ensure compliance to: BSC Design Control System, Medical Device Directive, Essential Requirements, international standards, labeling requirements, Quality System Regulation, export requirements, and regulatory requirements of pertinent regions. Monitors/researches changes in the regulatory and competitive environment, evaluates impact, and communicates to interested parties.

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.

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 products lines, special projects or strategic initiatives.

Requirements:
Bachelor degree in a scientific or technical discipline. RAC certification desirable.
A minimum of eight 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 device products. Strong technical understanding of relevant procedures, practices, and associated medical terminology.
Strong knowledge of clinical trial strategy 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.df-tc

Experience/Skills
See Description Above

Other desired skills:
Regulatory Affairs Project Manager
This job has expired.