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Regulatory Affairs Specialist

Job Description

Our client is a leading medical device company and is currently seeking an accomplished Regulatory Affairs Specialist to join the team. Here is an overview of the role:

1) The Regulatory Engineer/Regulatory Specialist will participate on engineering project teams to draft, assemble, and file documentation and submission materials to regulatory authorities, assuring submissions are accurate, and in conformance with the appropriate regulations.
2) He or she will track submissions and initiate internal communications and activities to adequately respond to agency inquiries and requests.
3) This individual will represent Regulatory Affairs on assigned project teams through all phases of product development; communicate regulatory requirements and the impact of regulations to the development team to ensure compliance for product development, labeling, and/or promotional issues.
4) The Regulatory Engineer/Regulatory Specialist will independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change and will review and approve product changes and product labeling to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines.
5) This individual is responsible for maintaining FDA Regulatory and Clinical communications documentation, will assist with FDA and Canada registrations and device listings, and will participate in design review meetings and attend scientific meetings/industry conferences as required.
6) Determines domestic and international Regulatory classification of devices.
7) Develops Regulatory submissions (510ks, PMAs, Design Dossiers, IDEs, etc.) for assigned projects.
8) Maintains understanding of medical device domestic and international Regulatory requirements.
9) Represents Regulatory Affairs on design teams on all phases of product development.
10) Provides Regulatory documentation for TDR binders as specified.
11) Reviews product changes through DCN process to assess regulatory implication.
12) Reviews design verification testing.
13) Maintain FDA regulatory and clinical communications.
14) Keeps FDA and Canada registrations and device listings current.
15) Assists with ongoing maintenance of regulatory binders.
16) Assist with tracking of non-IDE studies and publication efforts.
17) Position may require some (less than 10%) travel.
More questions? Want to know the Salary range? Keep reading.

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Job Requirements

1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people who have recent experience in regulatory affairs

This is a great time to join this fast-growing publicly traded medical device company, they have an experienced management team, a varied selection of innovative products and an empowering corporate culture that is focused on the long-term professional development of its employees.

Job Snapshot

Post Date 4/13/2014
Location North Lewisburg, OH
Employment Type Full-Time
Job Type Science, QA - Quality Control
Education Not Specified
Experience Not Specified
Manages Others Not Specified
Industry Biotechnology, Pharmaceutical, Medical Equipment
Required Travel Not Specified
Job ID USA-3153
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