As a regulatory affairs expert, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities
In this role, you will
Be a focal point for the RA team members to solve professional issues
Train the junior team members in their onboarding process and on specific skills and knowledge development.
Develop of regulatory strategies for product development and approval, as well as product lifecycle maintenance. Develop global strategy for product launch.
Prepare document packages for US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.
Implement MDR requirements related efforts in the organization
Assess product changes and their global regulatory impact.
Support license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post approval changes
Coordinate project submission timelines in multiple regions
Escalate issues that affect registration, regulatory compliance and continued lifecycle management of the product
Requirements: Minimum 5-8 years of experience in QA RA roles in the medical devices industry
Proven experience in cross-function work with R&D .
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
This position is open to all candidates.