Global Regulatory Affairs Specialist, Life-Saving Devices

VDyne; Maple Grove (MN); Sur place; USD 90 000 - 140 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory affairs

Regulatory strategy

Regulatory submissions

Communication

Documentation control

Formation

Bachelor's degree in Life Sciences or Engineering

Outils

Microsoft Office

Description du poste

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