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 Regulatory Affairs Associate Manager, you will be responsible for developing and driving the regulatory strategy, operations, and activities across the full product lifecycle. You will play a key role in broader business and organizational initiatives, contributing to management and strategic decision‑making.

You will ensure the creation and implementation of leading‑edge regulatory systems, processes, and practices, serving as the key technical expert for all regulatory aspects of the VB Spine business.

You will apply comprehensive strategic and advanced knowledge of regulatory and legal frameworks, requirements, legislation, and procedures.

You will mentor Regulatory Affairs professionals, lead a small team, and be recognized as a valued resource across departments.

What You’ll Do: 

• Providing strategic input and technical guidance on regulatory requirements to product development teams
• Provide strategic regulatory input to product development teams, offering technical guidance on requirements, risks, and pathways.
• Prepare, submit, and manage regulatory applications to global Health Authorities, including leading interactions, negotiations, and early issue identification to protect launch timelines.
• Ensure strong regulatory operations and systems, applying advanced knowledge of global regulations, legislation, and processes while monitoring and communicating evolving FDA and international requirements.
• Serve as the primary regulatory reviewer for labeling, advertising, promotion, change controls, and non‑conformance assessments to ensure compliance and appropriate submission strategy.

• Act as the regulatory lead on key cross‑functional project teams, providing technical leadership, clear communication, and timely escalation of issues or deviations.
• Drive regulatory strategy development, risk assessment, and global communication, while influencing the regulatory environment and supporting staff and vendor development.
• Mentor Regulatory Affairs professionals and lead a small team, operating with significant independence while reviewing progress with management.
• Evaluate regulatory risks of corporate policies and develop new regulatory policies, procedures and SOPs and train key personnel on them

What You Bring: 

• A university degree (starting from Bachelor’s or equivalent required), RAC certification
• Fluency in English
• At least 7 years of regulatory experience in the medical device industry, including experience planning, conducting, and overseeing regulatory assignments with significant autonomy
• Broad regulatory knowledge in areas such as regulatory pathways, risk‑benefit analysis, submissions, registrations, approvals, documentation, compliance, post‑market surveillance/vigilance, and distribution
• Skilled in reviewing progress, evaluating results, and recommending procedural improvements
• Strong analytical skills, strategic thinking capability and competence in applying scientific principles and logical thought processes in preparing regulatory documentation
• Ability to lead a team, influence others and handle increasing levels of responsibilities. Able to build relationships between RA and other groups (at Division and Corporate levels)
• Strong writing and verbal communication skills; ability to communicate effectively at multiple levels within the organization
• 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.