Senior Staff Regulatory Affairs Specialist_Spain

Location:Spain
Company:VB Spine

Looking for a career where your work truly matters? At VB Spine,you’llbe part of a mission-focused team that supports surgeons during life-changing spinal procedures.We’relooking for driven individuals ready to learn quickly, adapt under pressure, and grow in a dynamic, fast-paced environment.

As a Senior Staff Regulatory Affairs Specialist with Spanish and Portuguese, you will apply broad and advanced knowledge of regulatory and legal frameworks, requirements, legislation, and internal processes to guide regulatory strategy and execution. You will advise cross‑functional teams and leadership on complex projects, business initiatives, and strategic decisions requiring deep regulatory insight.

You will support new product development for domestic and international markets by developing and updating regulatory strategies in response to evolving global requirements. You will also support the full product lifecycle through obsolescence by assessing post‑launch changes to determine regulatory impact and required actions.

You will ensure regulatory compliance by conducting thorough assessments and preparing the appropriate submissions for product clearances and approvals from regulatory authorities.

In this role, you will be recognized as a key interdepartmental resource and subject matter expert.

WhatYou’llDo:

• Serve as a key project stakeholder, delivering regulatory value and meeting project milestones
• Demonstrate strong cross‑functional partnership aligned with RA mission and business strategy
• Drive divisional process improvements with limited supervision
• Assess regulatory requirements across the full product lifecycle to ensure compliance
• Anticipate regulatory risks and emerging issues, developing proactive solutions
• Prepare, submit, and track regulatory applications independently, providing timely updates
• Lead interactions and negotiations with regulatory authorities during submissions
• Perform independent peer reviews of submissions and oversee post‑market change impact assessments
• Support global registrations, monitor regulatory changes, review materials, lead regulatory strategy, participate in audits and working groups, and execute acquisition integration activities

What You Bring:

• A university degree (starting from a Bachelor’s or equivalent required), RAC certification
• Fluency in English, Spanish and Portuguese
• 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
• Ability to operate independently with strong communication skills and a collaborative approach, internally and externally
• 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.

Final compensation is determined on a case-by-case basis and considers factors such as experience level, skill set, and market conditions.