Regulatory Affairs Specialist

VDyne; Maple Grove (MN); On-site; USD 90,000 - 140,000; Full time

Job summary

VDYNE is a clinical-stage medical device company focused on transcatheter valve solutions for tricuspid regurgitation. We seek a Regulatory Affairs Specialist to support global regulatory activities across a growing portfolio and collaborate with Clinical, Quality, R&D, and Engineering to ensure submissions are well-prepared and compliant.

This role helps translate regulatory requirements into product development, labeling updates, and lifecycle planning, with opportunities to contribute to

Qualifications

• > Bachelor's degree in Life Sciences or Engineering.
• > Minimum 2 years of direct Regulatory Affairs experience with Class III/implantable devices.
• > Minimum 5 years in the medical device, healthcare, or life sciences industry.
• > Familiarity with FDA and European medical device regulations.
• > Strong organizational, written and verbal communication skills.
• > Ability to manage multiple priorities in a fast-paced environment.
• > Proficiency with Microsoft Office.

Responsibilities

• Monitor regulatory developments including standards, guidance documents, literature, and competitive products.
• Partner with core teams to communicate regulatory requirements and support regulatory strategy.
• Provide regulatory input to product development, lifecycle planning, and change control activities.
• Assess the regulatory impact of proposed design, labeling, manufacturing, and process changes and prepare supporting regulatory documentation.
• Facilitate product labeling content updates, translations, and labeling implementation across geographies.
• Partner with external global regulatory consultants on submission deliverables and regulatory reporting.
• Prepare and compile documentation for clinical and commercial submissions and annual reports.
• Support SAE and incident reporting, post-market surveillance, and recalls and field corrective actions.
• Monitor and maintain tracking tools used to manage regulatory deliverables and documentation.
• Support audits, inspections, and regulatory authority interactions as needed.
• Contribute to process improvements and help strengthen regulatory practices across the organization.

Skills

Regulatory affairs

Regulatory strategy

Regulatory submissions

Communication

Documentation control

Education

Bachelor's degree in Life Sciences or Engineering

Tools

Microsoft Office

Job description

• VDYNE is a clinical-stage medical device company focused on developing innovative transcatheter valve solutions for tricuspid regurgitation (TR), a life-threatening condition. With its patented side-delivery technology, VDYNE enables minimally invasive procedures, expanding treatment options for TR patients. Headquartered in Minneapolis, Minnesota, VDYNE is actively conducting clinical studies across the United States, Europe, and Australia.

The company's mission is to transform patient outcomes throughgroundbreaking advancements in medical technology.\This position will be instrumental in helping VDYNE achieve these ambitious goals.

THE ROLE

As a Regulatory Affairs Specialist at VDyne, you'll support regulatory operations and global clinical and commercial regulatory activities across an active and growing portfolio of transcatheter valve programs. You'll work alongside cross-functional teams — Clinical, Quality, R&D, and Engineering — to ensure regulatory requirements are understood, submissions are well-prepared, and compliance activities stay on track.

This role is ideal for someone who is analytically sharp, organized, and genuinely motivated by the regulatory work that sits at the center of bringing a life-changing therapy to patients.

WHAT YOU'LL DO

• Monitor State-of-the-Art developments including standards, guidance documents, literature, and competitive products
• Partner with core teams to communicate regulatory requirements and support regulatory strategy
• Provide regulatory input to product development, lifecycle planning, and change control activities
• Assess the regulatory impact of proposed design, labeling, manufacturing, and process changes and prepare supporting regulatory documentation
• Facilitate product labeling content updates, translations, and labeling implementation across geographies
• Partner with external global regulatory consultants on submission deliverables and regulatory reporting
• Prepare and compile documentation for clinical and commercial submissions and annual reports
• Support SAE and incident reporting, post-market surveillance, and recalls and field corrective actions
• Monitor and maintain tracking tools used to manage regulatory deliverables and documentation
• Support audits, inspections, and regulatory authority interactions as needed
• Contribute to process improvements and help strengthen regulatory practices across the organization

WHAT WE'RE LOOKING FOR

Required

• Bachelor's degree in Life Sciences or Engineering highly preferred
• Minimum 2 years of direct Regulatory Affairs experience with Class III and/or implantable medical devices
• Minimum 5 years of experience within the medical device, healthcare, or life sciences industry
• Familiarity with FDA and European regulations and medical device regulatory requirements
• Strong organizational skills, attention to detail, and effective written and verbal communication skills
• Ability to manage multiple shifting priorities in a fast-paced environment
• Proficiency with Microsoft Office

Preferred

• Experience supporting cardiovascular devices and clinical studies
• Demonstrated ability to work independently and generate solutions to complex regulatory challenges

WHAT MAKES THIS ROLE DIFFERENT

You'll be joining a small, collaborative regulatory team at a company where your contributions are visible and your work has a direct connection to patients who currently have very few treatment options. VDyne is actively conducting clinical studies across multiple continents — which means the regulatory work you do here is real, consequential, and happening right now. This is an opportunity to build meaningful regulatory experience at a pivotal moment in a company's growth, with the scope and visibility that a larger organization simply can't offer.

VDYNE is an equal opportunity employer.

We celebrate diversity and are committed to creating an inclusive environment for all employees.