Full-Time Regulatory Compliance Manager

Sirtex requires regulatory compliance to various global markets. The Regulatory Compliance Manager will be responsible for the overall management of global post-market compliance, including post-market surveillance, vigilance activities, adverse event filing, and post-market product/process changes. This person is also responsible for regulatory operations and management of global registrations.

This position will be hybrid (Woburn location) or remote.

PRIMARY RESPONSIBILITIES:

• Management and execution of post-market compliance to various regulations (EU MDR, Health Canada, US FDA, Australian TGA, etc.).
• Manage and execute review of events to determine complaint and reportability status. Complete applicable regulatory reporting.
• Manage and execute vigilance activities.
• Maintain and manage post-market surveillance reports.
• Provide regulatory guidance to cross-functional teams to ensure regulatory submission needs are met.
• Maintain and manage global regulatory approvals and licenses.
• Establish and maintain regulatory trackers, communicating status to management.
• Determine global registration priorities and resources for new product introductions.
• Approve advertising and promotional material, guiding cross-functional teams on regulatory updates.
• Maintain current knowledge of relevant laws, regulations, and industry standards.
• Participate in regulatory inspections as needed.
• Anticipate regulatory obstacles and develop solutions.

EDUCATIONAL PREREQUISITES AND SKILL REQUIREMENTS:

• Bachelor's degree or higher
• Minimum 7 years of medical device/pharmaceutical experience, with 2+ years of proven project management experience in regulatory affairs.
• Knowledge of Quality System requirements and FDA/International product approval process.
• Ability to prepare and present technical data to all levels of the organization and regulatory bodies.
• Proven leadership skills to guide and develop team members.
• Proven ability to lead and work effectively in cross-functional teams
• Strong organization, project management, and time management skills

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