Associate Director, Regulatory Affairs - Remote

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Requirements:

• Minimum bachelor’s degree in engineering or science required; Master’s degree preferred.
• At least ten years relevant experience required; medical device industry experience preferred.
• Experience working with global cross-functional teams highly desirable.
• Excellent communication skills, both written and verbal.
• Ability to manage multiple priorities effectively.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Must be able to work independently and make decisions within defined guidelines.
• Knowledge of U.S., Canadian, and International medical device regulations required.
• Strong analytical skills and attention to detail.
• Demonstrated project management skills.

Responsibilities:

• Work with internal teams including R&D, Marketing, Quality Assurance, and Operations to develop regulatory strategies for products.
• Prepare and submit applications to Health Canada and FDA (and international regulators as appropriate) for approval/clearance of new products, labels, packaging, promotions, etc.
• Develop compliance programs for all regulations applicable to our business.
• Maintain knowledge base regarding regulatory requirements in countries where we market products.
• Coordinate interactions between external consultants and internal staff to ensure timely completion of assigned projects.
• Provide technical assistance and training to sales and marketing personnel on specific regulatory issues related to their products.
• Monitor changing regulatory environments and communicate impacts to internal stakeholders.
• Develop policy positions on proposed legislation and regulations affecting our industry.
• Travel to trade shows and customer sites to represent the Company in regulatory matters.