Sr. Regulatory Affairs Specialist

Join a team that is changing millions of lives.

Transforming smiles. Transforming lives. Transforming an industry.

At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our teams are constantly pushing the boundaries of what’s possible.

Ready to join us?

About This Opportunity

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

In this role, you will…

• Actively contribute in the development of regulatory strategies for product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities with different partners and their global strategy for product launch.
• Perform coordination and preparation of document packages for US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.
• Coordinate and implement MDR requirements related efforts in the organization
• Assess product changes and their global regulatory impact.
• Lead or compile all materials required in submissions, 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
  
  

• BA or B.Sc. degree is required.
• A degree in engineering, materials, chemical sciences is preferred.
• Minimum of 5 years relevant/regulated industry experience.
• Demonstrated ability to communicate regulatory requirements clearly, accurately, and concisely
• Strong knowledge of global health authority laws, regulations, guidance and the regulation submission route available for assigned products.
• MDR knowledge and preferably already experience in implementing it
• Ability to confront new Regulation/ Guidance document
• Experience with previous 510(k) submissions
• Experience with previous technical file dossiers
• Experience developing regulatory strategies and an understanding of the product development process
• Expertise in product development and its application in global regulatory strategy