The Company:

Carestream Health, Inc., formerly Eastman Kodak Company’s Health Imaging Business is an internationally recognized provider of medical and dental imaging systems, healthcare information solutions; molecular imaging systems; and non-destructive products.

ONEX, one of Canada’s largest corporations, acquired the Eastman Kodak’s Health Imaging Division in a multi-billion-dollar transaction in May 2007. Upon closing, the business began operating as Carestream Health, Inc., an independent subsidiary of ONEX Corporation of Toronto. Prior to becoming Carestream Health, Kodak’s Health Group recorded 2006 revenues of more than $2.5 billion. Carestream Health has approximately 7,500 employees, serving tens of thousands of customers in more than 150 countries.

Carestream Health’s many success stories include:

• Products and services from Carestream Health are present in 90% of hospitals worldwide.

• Owning more than 1,000 patents for medical and dental imaging and information technology.

• Selling nearly two out of every five computed radiography (CR) systems in the U.S. and Canada, and being the only company that designs, manufactures and sells both CR and DR (digital radiography) systems.

• Gaining share in the healthcare IT solutions market and building an installed base of more than 1,100 systems worldwide.

• Carestream Health worldwide headquarters is located in Rochester, New York.

Position Overview:

The Regulatory Affairs Department at Carestream Health is a division of the Corporate Technology Office.  Activities are dedicated in support of product development and commercialization and post-market surveillance including adverse event reporting, international product registrations and oversight for medical device recalls.  Our portfolio includes Class I, II and III devices some of which are exempt from premarket notification while others are PMA devices.  

Reporting to the CTO Regulatory Affairs, The Regulatory Affairs Manager provides post-commercialization and post-market regulatory support to Carestream medical device products both domestically and internationally. This includes regulatory support for current product engineering, manufacturing, servicing and post-market surveillance activities. The Regulatory Affairs Manager will be required to prepare product files for submission for Class I, Class II medical devices and compliance to domestic and international governments to obtain approval to market medical devices

The Regulatory Affairs Department offers you the opportunity to work in a very innovative and exciting environment where you will be exposed to and challenged with a broad spectrum of product submissions and global regulatory requirements.  For the candidate who desires to continually develop and hone their regulatory skills this is a great job!

This is a full-time, regular position, not a consulting role.  Carestream Health offers very competitive compensation including excellent employee benefits and a great work environment.  You must be authorized to work in the United States; company sponsored immigration is not offered.  Relocation assistance is available for qualified candidates.

Primary Responsibilities:

· Assist in preparation of post-marketing approval applications, such as Pre-Market Application (PMA) Supplements.

· Communicates with commercialization Regulatory Affairs manager regarding Product Hazard Risk Management, significant post-launch design changes etc.

· Prepares license amendments and annual reports to Therapeutic Directorate of Health Canada regarding Class 1 and Class 2 medical devices

· Provides documents supporting international product registrations, approvals or licenses for additional marketing approvals after product launch.

· Proficient with, communicates and verifies compliance with new regulatory requirements that impact product that is on the market

· Works closely with cross-functional teams and individuals in providing regulatory oversight for post-launch product development activities and updates post-commercialization deliverables such as the Declaration of Conformity, Technical Construction File, etc.

· Works with current product engineering/manufacturing staff to review and approve product modifications, including engineering change orders, drawings, test plans & reports, field manual or parts list updates or supplier certifications

· Participates in Corrective Action Teams post-launch.

· Reviews and approves all post-launch customer publications, labels, labeling and marketing advertising and/or promotional materials for products marketed by the company.

· Responsible for coordination, documentation and submission of Medical Device reportable events.

· Provides training on applicable medical device regulations.

· Owns Regulatory Affairs Standard Operating Procedures processes that apply. (i.e. Post Market Surveillance, EMDR Process, Electronic Radiation Report, etc.)

· Participates in product quality investigations and Regulatory Agency inspections including internal and external audits

· Functions as a product line expert within Regulatory Affairs.

Provides guidance and support to QA and QE for post market adherence to GMPs, QSRs, and GCPs.