Director Of Regulatory Affairs

Director of Regulatory Affairs

We are seeking an experienced Director of Regulatory Affairs to create and execute global regulatory strategies for our products, in alignment with business goals. This role will serve as a strategic advisor to the executive team and develop a high-performing regulatory affairs team to support company objectives across product lifecycles.

Responsibilities

• Create and execute global regulatory strategy for all products in alignment with business goals.
• Serve as a strategic advisor to the executive team on the regulatory implications of product and process changes.
• Develop and lead a high-performing global Regulatory Affairs team that supports company objectives across product lifecycles.
• Oversee department budget planning and resource allocation to ensure alignment with regulatory and business priorities.
• Ensure Regulatory Affairs participation on cross-functional project teams supporting new product development and product modifications.
• Lead timely renewals of global licenses, certificates, and product registrations.
• Provide guidance on the application of external standards across all projects.
• Maintain complete, audit-ready regulatory documentation and manage global submission packages.
• Direct regulatory activities related to field corrective actions and ensure appropriate product re-submissions and ongoing support in maintaining ISO / CE Mark certifications and related regulatory audits.
• Monitor evolving global regulatory requirements and assess their impact on products and company strategy.
• Conduct regulatory assessments for reportability and submit FDA MDRs and international vigilance reports as needed for tissue-based products.
• Review Engineering Change Requests (ECRs) for global regulatory impact.
• Lead or participate in regulatory review of promotional materials.
• Author, review, and approve internal procedures related to regulatory affairs operations and compliance.

Essential Skills

Additional Skills & Qualifications

Work Environment

This is a hybrid role requiring 2-3 days on-site each week. We are open to candidates willing to relocate, with relocation assistance provided in the form of a signing bonus.

Job Type & Location

This is a Permanent position based out of Saint Paul, Minnesota.

Pay and Benefits

The pay range for this position is $250000.00 - $275000.00 / yr. Comp : $250 - $275k base + 25% STI + Stock Options

Application Deadline

This position is anticipated to close on Oct 10, 2025.