Regulatory Affairs Associate - exp

Company Name:
Comrise Inc.
Senior Regulatory Affairs Specialist
Bachelor's Degree in Scientific discipline or equivalent work experience; Prefer RAC certification
Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines. Ensure compliance with all US, EU and SO international requirements and corporate policies and procedures regarding submissions for market approval of medical devices/combination products.
3+ years experience in FDA regulated industry
Working knowledge of Medical Device Regulations (FDA required, international a plus)
Demonstrated direct interaction with FDA reviewers/inspectors
Demonstrated interpersonal, written, oral, communication, organizational and planning skills
Demonstrated computer skills (Excel, Work, PowerPoint)
Demonstrated understanding of scientific principles
Demonstrated sustained performance experience in a large roll. Duties:
Participate on product development teams to insure US and other international regulatory requirements are incorporated as part of the development process
Author submissions and other regulatory documents to obtain approval to bring new or modified products to market
Assist in post market submissions (progress reports, annual reports etc.)
Support marketing, R&D; and manufacturing teams in regulatory assesment of proposed changes or product transfers
Provide regulatory leadership to project teams regarding strategic pathways to market
Interface and coordinate with the FDA and other regulatory agencies on submissions, approvals or other issues
Establish and maintain regulatory information systems both electronically and hard copy
Interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnell
Review and approve change control, etc. while considering both US and international regulatory requirements
Prepare and update US product listings
Communicate any FDA correspondence on submissions to the appropriate team(s) and RA management
Participate in BPX project teams
Label, market, and transfer product and literature review pre and post market
Construct technical file and Design Dossier
Assist the RA Manager and others with the development, implementation and maintenance of regulatory SOP's
Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of company Orthopaedics Business Process Excellence initiative.
Mentor to other members of the Clinical Research team.
Date: 2014-08-29
Country: US
State: PA
City: Malvern
Postal Code: 19355
Category: Other
Job Type: Contract (Full-Time)

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