Associate Director, Regulatory Affairs - Hybrid

BD • San Diego, CA

279d • $169,800 - $280,300

About The Position

As Associate Director of Regulatory Affairs, you will lead regulatory activities for new product development, labeling changes, promotional requests, and other regulatory submissions in both Canada and the United States. This position reports to the Vice President of Global Regulatory Affairs. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

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.

Benefits

• Competitive salary range of $169,800.00 - $280,300.00 USD Annual.
• On-site collaboration to foster creativity and innovation.
• Flexibility and work-life balance.
• Opportunities for professional development and growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree