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AlignTech Sr 3D Process Engineer United States, California, San Jose 370170977
Yesterday
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
- Employment Type
- Full Time
- Workplace type
- Reporting To
- Aviva Touati
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
In this role, you’ll need …
- BA or B.Sc. degree is required.
- A degree in engineering, materials, chemical sciences is preferred.
- 10 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
At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:
- Health and well-being programs to keep you thriving in both body and mind.
- Employee-exclusive discounts on Invisalign products.
- Learning opportunities through online learning resources and support for your individual development plans.
- Inclusive, global workplace that fosters collaboration, recognition and belonging.
Country and/or role specific details will be shared with you by your recruiter during the interview process.
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