JobMesh

Staff Regulatory Affairs Specialist

VB Spine · PL

Location: Poland Company: VB Spine Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports su...

Job description

Location: Poland Company: VB Spine Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We’re looking for driven individuals ready to learn quickly, adapt under pressure, and grow in a dynamic, fast-paced environment. As a Staff Regulatory Affairs Specialist , you will be responsible for planning, organizing, and implementing regulatory strategies and activities required to obtain approval for new and updated product lines. You will ensure compliance with regulatory requirements, as well as corporate and Spine division policies related to submissions and market authorization for medical devices and combination products. This role includes active participation in cross‑functional teams from early development through regulatory approval, applying scientific principles and sound reasoning to prepare high‑quality regulatory documentation. What You’ll Do: - Participate in product development teams to ensure regulatory requirements are integrated throughout the development process - Author regulatory submissions and documentation to obtain approval for new or modified produ...