16 ott - Bardi
VB Spine
Location:
Remote - Europe
Company: VB Spine
VB Spine is expanding its European organization, and we are now finalizing recruitment for our main Regulatory Affairs team. The core team is based in Warsaw, Poland, and we are also open to hiring experienced Regulatory Affairs professionals who can work remotely from Spain, Italy, or France.
This is an exciting opportunity to join a growing medical device company and become part of a collaborative, international Regulatory Affairs team working across Europe
As a 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 m
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