"Alerted.org

Director of Regulatory Affairs

Structural Heart | Medical Device | Relocation Offered

Job Description

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

+ Extensive Regulatory Affairs Leadership with a proven track record in leading regulatory strategy and submissions for Class III medical devices.

+ Hands-on experience with IDE Products / PMA submissions, FDA inspections/audits, and direct FDA interactions.

+ Demonstrated ability to secure and maintain EU approvals under MDR, including notified body interactions.

+ Experience navigating multiple geographies beyond U.S./EU (e.g., APAC, LATAM, Canada).

+ Successful experience growing, leading, and developing regulatory teams.

+ Comfortable setting global regulatory strategy while also drafting and reviewing submissions.

+ Strong communication skills to influence senior leadership and represent the company externally.

+ Local to MN or willing to relocate.

Additional Skills & Qualifications

+ Direct experience with transcatheter or tissue valves (especially TAVR/TMVR).

+ Experience with bovine pericardium tissue.

+ Familiarity with IDEs, clinical study design input, and regulatory support for global pivotal trials.

+ Background in both entrepreneurial environments and large medtech companies.

+ Experience presenting regulatory milestones and risk assessments at the board level.

+ RAC certification or equivalent is a plus.

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

Workplace Type

This is a hybrid position in Saint Paul,MN.

Application Deadline

This position is anticipated to close on Sep 25, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.