Regulatory Affairs Manager

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Job description

Essential Functions:

• Oversees assigned staff. Schedules, directs, assigns work, trains, and ensures tasks/projects are completed in a timely manner and adheres to operational standards.
• Interviews, hires, trains, and develops employees. Motivates employees, assists in goal setting, provides development opportunities and performance feedback, addresses complaints and provides resolutions. Addresses all employee relations matters in a timely manner in coordination with Human Resources.
• Reviews and develops standard operating procedures (SOPs) and departmental
• Develops and implements regulatory strategy to ensure timely release of products in the US, Canada, and Latin American (LATAM)
• Coordinates with various LATAM subsidiaries to submit documentation required for registration of products in each of the markets.
• Reviews and advises on proposed labeling, packaging, advertising and promotional materials. Communicates with US FDA, Health Canada, and global regulatory agencies.
• Participate in risk management activities and product realization processes.
• Analyzes and develops reports related to department
• Manages the preparation, submission, and submission tracking of FDA (510k) and International
• Maintains licenses and certifications from regulatory
• Processes change requests; prepares and files necessary regulatory documentation as
• Prepares US MDRs and events under international medical device vigilance systems as
• Oversees customer complaints to ensure appropriate action and
• Supports internal, external, and third-party
• Maintains awareness of US and global regulatory requirements/environment and effectively communicates these requirements throughout the organization.
• Provides guidance and assist other departments and divisions to ensure continued compliance and timely market release.
• Acts as the Recall Coordinator when required.
• Performs other related duties and projects as business needs require at direction of

Education and Experience:

• Bachelor's degree in a scientific discipline,
• Minimum seven (7) years of regulatory affairs experience.
• Previous experience working with FDA 510(k)
• Previous experience working with Health Canada and LATAM submissions, preferred.

Special Requirements/Certification:

• Regulatory Affairs Certification (RAC), preferred.

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