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Regulatory Affairs Specialist
Ref No.: 18-07356
Location: somerville, New Jersey
Position Type:Direct Placement
Start Date: 06/18/2018
Candidate will be responsible for supporting regulatory affairs activities which will simplify customer's current wound closure platform by consolidating product codes, consolidating Instructions for Use, transferring manufacturing locations, harmonizing packaging, and harmonizing indications for use. The candidate is expected to have working knowledge of U.S., E.U., and International Regulatory requirements and be able to apply this knowledge to ensure that all project workstreams maintain compliance to world-wide regulatory requirements. Candidate will be responsible for creating and submitting to various world-wide health authorities. Candidate will be responsible for ensuring that the various workstreams in assignment are completed on-time and in compliance with world-wide regulations and Directives.

Job Responsibilities:
• Work in cooperation with customer personnel who maintain ultimate direction over the work.
• Support U.S., EU, and International regulatory affairs activities for Project Complexity.
• Collaborate with cross-functional project team members and commercial partners to oversee the regulatory aspects of Complexity Management project changes and ensure the project timelines are met and in compliance with world-wide regulations and Directives.
• Prepare US, EU, and International Regulatory impact assessments for design, packaging, manufacturing, and labeling changes.
• Prepare submissions to U.S., EU, and International health authorities, as required.
• Ensure all regulatory documents are complete, accurate, and well-maintained.
• Prepare regulatory labeling requirements specifications for new and modified products and review product labeling to ensure compliance.
• Respond to product information requests.
• Research and collect information and data to support periodic reports to regulatory agencies
• Represent Regulatory Affairs on cross-functional project teams.

JOB REQUIREMENTS:
• Must have at least 5 years of Regulatory Affairs experience in the medical device industry.
• Must have working knowledge of U.S., E.U., and International Regulatory requirements and be able to apply this knowledge to ensure that all project work streams maintain compliance to world-wide regulatory requirements
• Must have previous experience with document management systems and change control systems.
• Must be able to work independently, utilizing research and problem solving skills, and the willingness to learn new skills.
• Must have excellent written, verbal communication and presentation skills.
• Must be able to communicate clearly, succinctly and effectively.
• Must have solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
• Must be able to work in a timeline-driven environment