Associate Director, Regulatory Affairs Devices and Combination Products - Remote

Overview

The Associate Director, Regulatory Affairs Devices and Combination Products works with internal and external partners to deliver products to patients. This role supports regulatory objectives for the company’s development and marketed device/combination products, including coordination and management of global submissions.

In Short

• Develops and prepares pre-market regulatory submissions.
• Manages regulatory applications for devices and combination products.
• Develops device strategies for meetings with regulatory agencies.
• Trains, develops, and mentors individuals.
• Analyzes legislation and provides guidance to the organization.
• Represents Regulatory Affairs on product development teams.
• Supports regulatory intelligence and policy activities.
• Manages products and change control in compliance with regulations.
• Provides regulatory support for Agency audits/inspections.
• Focuses on eye care devices and next generational eye care medicinal delivery products.

Requirements

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• 12+ years of pharmaceutical or industry experience.
• 5+ years in quality systems and regulatory affairs.
• Proven 7+ years in a leadership role.
• Strong communication skills, both oral and written.
• Experience developing global regulatory strategies.
• Experience working with Health Authority.
• Relevant advanced degree preferred.
• Certification in regulatory affairs is a plus.
• Experience in medical device/combination products is preferred.

Benefits

• Comprehensive benefits package including paid time off.
• Medical, dental, and vision insurance.
• 401(k) plans for eligible employees.
• Participation in short-term and long-term incentive programs.
• Opportunities for professional development and training.