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Director of Regulatory Affairs - Medical Devices

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POST DATE 9/16/2016
END DATE 10/15/2016

Engineering Resource Group, Inc. Frazer, PA

Frazer, PA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Min Salary
Max Salary
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per year


Permanent position for a Director of Regulatory Affairs to prepare and maintain US and international regulatory submissions, support product development with regulatory guidance, and maintain product and corporate regulatory requirement compliance with medical device regulations and applicable laws (HIPAA, Code of Conduct, etc). Serve as liaison with FDA and international regulatory authorities. Negotiate for marketing authorization. Manage all regulatory projects, developing and executing regulatory plans. Co-write, review, and edit regulatory submissions and submit documentation.Manage and maintain ongoing submissions such as annual reports, medical device facility registrations and device listing. Coordinate tracking of regulatory documentation, including: correspondence, labeling, data packages, forms, and submissions. Review, advise and provide input to ensure compliance to applicable global, federal, state and local government medical device regulations.Participate as regulatory expert in quality system and licensing audits. Lead efforts in approval of product labeling and promotional materials, assuring regulatory requirements are met, safety warnings and precautions are adequate, and all product claims are properly supported. Provide regulatory review and approval of proposed product design and specification change plans and assess impact on registrations. Monitor and ensure compliance with GCP, HIPAA, Codes of Conduct, FCPA and Sunshine Laws through auditing and main


BS Degree in life sciences or engineering.Minimum 5 years of experience
in medical device regulatory affairs. International experience is a plus.Proven
ability to prepare device applications (i.e. IDEs, 510(s), Technical Files,
etc). Knowledge of GCP /ISO14155, GVP and Quality Systems requirements.
Knowledge of medical device requirements including QSR, ISO13485, ISO14971.
Experience with a complete medical device product development cycle from
product development through marketed product.Ability to review and conduct
gap analysis against new FDA guidance or international requirements. Able
to seek out and provide and negotiate strategic regulatory guidance for
US and OUS products.Able to manage complex projects and timelines.Self-starter
with excellent organizational skills, strong problem solving skills, attention
to detail, and strong oral and written communication skills. Excellent
computer aptitude and document formatting skills.

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