Sr. Manager Regulatory Affairs Emea

**Join a team that is changing millions of lives.** Transforming smiles, changing lives 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 diverse and collaborative teams are constantly pushing the boundaries of what’s possible. Ready to join us? **About this opportunity** The purpose of this position is to manage an international team of regulatory professionals supporting pre-market and post market regulatory activities for Align Technology’s hardware and software products in the EMEA, non-European markets. This to ensure timely and effective product registration of new product introductions and /or timely and effective product re-registration after changes of the product by the legal manufacturers or changes in the regulations, ensuring continuous market access from a regulatory perspective. **In this role, you will** - Manage the EMEA RA team for EMEA, non-European regions. The regions are CIS, Middle East and Africa. - Make a yearly risk-based capacity plan to ensure that the RA team has enough employees to support all agreed regulatory product registrations of new product introductions or changed products, as well as maintaining product registration license valid after changes of applicable local regulations. - Make a yearly risk-based RA strategy to timely and effectively obtain product registration licenses from applicable health authorities to obtain regulatory market access according product launch plans in agreement with applicable stakeholders, e.g. Marketing Department, the Project Management Organization and the legal manufacturers RAQA and R&D teams. - Ensure that Regulatory Affairs is represented on project teams, providing strategy and unambiguous guidance on complying with local regulatory requirements; assist in developing rationale and documentation for new product development, product changes, testing, design reviews, labeling changes, packaging changes, material changes, claims, etc. Guide project teams in creating documentation for submissions, writing summaries, and other necessary documentation including creating/maintaining Technical Files. - Effectively manage and prepare regulatory documents and submissions to ensure timely approvals. - Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. - Select and collaborate with most effective and efficient third party service providers, and have appointed most effective and efficient authorized representatives in markets where Align is not directly present. Note that this might be the respective selected distributor in that market. - Ensure effective and efficient post market surveillance execution meeting local regulatory requirements. - Maintain excellent working relationships with regulatory authorities. - Support external inspections and audits by international regulatory authorities, Notified Body, and / or FDA. - Attract, develop, and retain key talent for Align’s regulatory affairs function. - Anticipate and advise on future regulatory trends and direction. **In this role, you’ll need ** - Minimum of Bachelor’s Degree in Science (Life Science) or Technical discipline is required; - MSc in LifeScience or Quality Engineering degree is desired; - 8 - 10 years of experience in an international Regulatory Affairs function within the medical device or pharmaceutical industry. - 5 years minimum experience in supervisory or managerial roles. - A broad understanding of the Quality System regulations for medical devices (EU-MDR 2017/745, 21 CFR, ISO 13485, CMDCAS, etc.). - Experience with successful product registrations in CIS countries, Middle East and / or African markets. - Experience with Medical Device software is preferred - Fluently in English (reading, writing, and conversation). At least one other language is preferred, e.g. French, Arabic or Russian. **Sound like a good fit?** Great Click the "Apply" link to let us know you are interested. Not the right fit? Don’t worry, Align is quickly growing so we are creating more opportunities to expand our Align family. Please consider joining our Talent Network to receive notifications about future jobs or sharing this opportunity with others in your network. **About Align** Align Technology is a publicly traded medical device company that is **transforming smiles and changing lives**. Our global team of talented employees develop innovative technology, tools and treatment options to help dental professionals worldwide achieve the clinical results they expect. Our digital ecosystem combines the power of technology to create beautiful smiles through the integration