Our client is currently seeking a Lead Regulatory Affairs Coordinator, preferably a professional who has worked with Medical Devices. This role will require a detail oriented individual capable of managing multiple tasks while keeping the big picture in mind. Up to 20% travel may be required.
* Support Regulatory Affairs product life cycle management and sustaining activities.
* Responsible for support of sustaining regulatory activities at both sites including regulatory evaluation of product changes, marketing collateral, labeling, etc.
* Responsible for review and drafting of procedures to meet corporate standards and relevant regulatory requirements.
* Reporting project status and progress to management.
* Must be proficient in Microsoft office (Work, Excel, Outlook).
* Bachelors Degree in Engineering or Healthcare related field preferred.
* Regulatory, Quality or R&D experience in a regulated industry.
* M&A experience a plus Experience interacting with FDA, Notified Bodies or Other Health Authorities Preferred.
* Strong communication skills and experience in cross functional teams are necessary.
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