Senior Regulatory Affairs Specialist

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. Senior 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, while operating with increasing independence and contributing expert regulatory insight. You will ensure compliance with regulatory requirements, as well as corporate policies governing 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 judgment to evaluate product safety, efficacy, and regulatory pathways across a broad range of technologies. What You’ll Do: Participate in product development teams to ensure regulatory requirements are integrated throughout the development process Prepare regulatory submissions and documentation to support market approval for new and modified products Support post‑market regulatory activities, including progress reports, annual reports, and updates to U.S. product listings and EU registrations Collaborate with Marketing, R&D, and Manufacturing to assess regulatory impact of product and manufacturing changes, transfers, and proposed updates Provide guidance on regulatory pathways and strategies, escalating to senior regulatory professionals as needed Coordinate with FDA, Notified Bodies, Competent Authorities, and other regulatory agencies on submissions, approvals, and regulatory inquiries under appropriate supervision Conduct labelling, marketing, literature, and product transfer reviews; maintain regulatory documentation systems; and support creation of CE Technical Files and Design Dossiers What You Bring: A university degree (starting from Bachelor’s or equivalent), RAC certification preferred Fluency in English At least 2 years of regulatory experience in the medical device or pharmaceutical industry; Working knowledge of Medical Device Regulations (FDA and EU required) Strong interpersonal, written, oral, communication, organizational and planning skills Working knowledge of personal computer systems and desktop office applications About VB Spine: VB Spine, LLC is the largest privately held spine company and among the largest family-owned medical technology companies in the world. Our globally recognised identity as innovators and stewards of the spine industry reflects our commitment to patient outcomes first. With a comprehensive product portfolio and a large and growing global distribution network, VB Spine delivers specialised solutions that address critical needs in spine surgery and enhance patient outcomes. VB Spine is a strategic partner to Stryker with access to Mako Spine and Copilot. Focused on people, partnerships and operational excellence, VB Spine ensures healthcare professionals have access to the tools and resources needed to provide the highest standard of care. Compensation: Pay for this role is competitive and based on experience, with qualifications and performance taken into account. This role is with a hybrid work model. While non-local candidates may apply, relocation and housing assistance are not provided, and candidates are responsible for all related expenses. Final compensation is determined on a case-by-case basis and considers factors such as experience level, skill set, and market conditions. #J-18808-Ljbffr