Sr. Regulatory Affairs Specialist

Position Summary

The Senior Regulatory Specialist is someone who can work independently and is responsible for fulfilling regulatory compliance requirements by applying an understanding of regulatory standards and regulations for medical devices, pharmaceuticals and biologics.

Position Responsibilities

• Responsible for developing regulatory strategies and plans for new or modified products.
• Identifies and defines contents for regulatory submissions for US FDA, Health Canada and USDA. Influences the testing strategy and test report contents. Supervises the assembly of the regulatory submissions.
• Write and prepare submissions to regulatory agencies.
• Develop and execute strategies for responses to US FDA, Health Canada, and government agency questions with cross-functional team.
• Assess product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations and prepare submissions, as required, by geography.
• Maintain current and grow regulatory knowledge of North American regulations, guidelines, and standards and apply appropriate implementation strategies.
• Represent regulatory on project teams to develop regulatory strategies, including reviewing the various specifications and testing plans/reports, keeping in mind defined target market.
• Interpret the intent of regulations and policies and provide such information to project teams and management. Work with the organization to meet the requirements.
• Review product labeling and ensure compliance with applicable North American regulations.
• Negotiate and interact with and/or directs others in interacting with Regulatory Agencies during the development and review process to ensure submission approval.
• Identifies the need for, prepares, and conducts regulatory related training for the business.
• Reviews advertising and promotional materials for compliance with global regulations; analyses and recommends appropriate changes.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Identify the need for new or modified regulatory procedures and participates in development and implementation.
• Collaborates with individuals at different levels and develops or is responsible for the development of solutions to problems.
• Makes recommendations for improvements within the organization.
• Other tasks, as required.