Regulatory Affairs Specialist

DescriptionIn 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 partnersKey ResponsibilitiesActively 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 partnersInteract 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 mitigationsMonitor and document post marketing activities, analysis of trends, vigilance processes.Respond to Information requests from regulatory AuthoritiesExplore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and prioritiesUtilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post-approval changesSkills, Knowledge & ExpertiseBA or B.Sc. degree is required.A degree in engineering, materials, chemical sciences is preferred.5 years relevant/regulated industry experienceDemonstrated ability to communicate regulatory requirements clearly, accurately, and conciselyMDR knowledge and preferably experience in implementing itAbility to confront new Regulation/ Guidance documentExperience with previous 510(k) submissionsExperience with previous technical file dossiersExpertise in product development and its application in global regulatory strategyAbout Align TechnologyYour growth and well-being: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.Discover Align:We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.Align’s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.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.As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.Eager to learn how we embrace our global differences and nurture employee well-being?Explore Align's culture here!Want to discover more about exocad and Cubicure? Click on their names for additional information.Applicant Privacy Policy:Review our Applicant Privacy Policy for additional information.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.