Regulatory Affairs- Maternity leave replacement

Department: Quality

Location: EMEA-Israel

Description

About this opportunity

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
  
  

Skills, Knowledge & Expertise

In this role, you’ll need …

• 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
  
  

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Global Diversity Statement

At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.

Equal Opportunity Statement

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.