Staff Regulatory Affairs Specialist

VB Spine, LLC; Warszawa; Hybrid; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

VB Spine, LLC is seeking a Staff Regulatory Affairs Specialist in Warsaw, Poland, to lead regulatory strategies for medical devices and combination products across development through approvals. You will ensure compliance with submissions, market authorization, and global regulatory requirements.

The role requires a university degree (Bachelor’s or equivalent), RAC preferred, and at least 5 years of regulatory experience in the medical device industry, with strong English communication and

Qualifications

• Bachelor’s degree required (starting from a Bachelor’s or equivalent), RAC certification desired.
• Fluency in English and 5+ years of regulatory experience in the medical device industry.
• Strong interpersonal, written, oral communication, organizational and planning skills.

Responsibilities

• 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 products.
• Support post‑market submissions, including progress reports and annual reports.
• Partner with Marketing, R&D, and Manufacturing to assess the regulatory impact of proposed changes or product transfers.
• Advise teams on appropriate regulatory pathways and strategies for market access.
• Interface with regulatory authorities regarding submissions, approvals, and regulatory inquiries.
• Maintain regulatory information systems and ensure accurate electronic and hard‑copy documentation.
• Interpret new and existing regulatory requirements and communicate implications to relevant teams.
• Review and approve engineering changes and manufacturing modifications in alignment with global regulatory requirements.
• Conduct labelling and collateral reviews, maintain IFU English Master Matrix, and support creation or updates of CE Technical Files and Design Dossiers

Skills

Regulatory experience

Fluent English

Interpersonal skills

Written communication

Oral communication

Organizational skills

Planning skills

Computer skills

Education

Bachelor’s degree or equivalent

RAC certification

Job description

Location: Warsaw, 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 products
• Support post‑market submissions, including progress reports and annual reports
• Partner with Marketing, R&D, and Manufacturing to assess the regulatory impact of proposed changes or product transfers
• Advise teams on appropriate regulatory pathways and strategies for market access
• Interface with regulatory authorities regarding submissions, approvals, and regulatory inquiries
• Maintain regulatory information systems and ensure accurate electronic and hard‑copy documentation
• Interpret new and existing regulatory requirements and communicate implications to relevant teams
• Review and approve engineering changes and manufacturing modifications in alignment with global regulatory requirements
• Conduct labelling and collateral reviews, maintain IFU English Master Matrix, and support creation or updates of CE Technical Files and Design Dossiers

What You Bring

• A university degree required (starting from a Bachelor’s or equivalent), RAC certification desired
• Fluency in English
• At least 5 years of regulatory experience in the medical device industry;
• Broad regulatory knowledge in areas such as regulatory pathways, risk‑benefit analysis, submissions, registrations, approvals, documentation, compliance, post‑market surveillance/vigilance, and distribution
• 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.