Regulatory Affairs Specialist

Department: Quality

Location: EMEA-Israel

Description

In this position, 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

• Actively contribute in the development of regulatory strategies for software and product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities and global strategy for product launch.
• Define and prepare document packages for US FDA regulatory submissions, EU MDR Technical Files, and international packages.
• Assess product changes and their global regulatory impact.
• Ensure timely 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
• Monitor and document post marketing activities, analysis of trends, vigilance processes.
• 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
  
  

• BA or B.Sc. degree is required.
• A degree in engineering, materials, chemical sciences is preferred.
• 5 years relevant/regulated industry experience
• Demonstrated ability to communicate regulatory requirements clearly, accurately, and concisely
• MDR knowledge and preferably experience in implementing it
• Ability to confront new Regulation/ Guidance document
• Experience with previous 510(k) submissions
• Experience with previous technical file dossiers
• Expertise in product development and its application in global regulatory strategy