Transforming smiles,
changing lives.
Sr. Regulatory Specialist I, Ads, Promos & Labeling
This position is ideal for mid-level regulatory professionals to join the Regulatory Operations and Compliance team as a Sr. Regulatory Specialist I, Ads, Promos & Labeling, managing key regulatory processes and ensuring compliance across global markets for advertisements and promotional materials, labeling, and UDI. Partnering with cross-functional teams, you’ll provide expert regulatory insights and support to ensure compliant product launches and maintain regulatory standards throughout the product lifecycle. This role is crucial in maintaining Align Technology’s regulatory compliance and supporting successful regulatory operations and compliance processes globally.
Role expectations
Global Ads & Promotional Material Regulatory SME:
- Act as the RA point of contact for all advertisements and promotional material assets, globally and in North America (iTero and Invisalign).
- Review marketing advertisements and promotions for regulatory compliance within the marketing material review platform.
- Provide guidance on regulatory requirements for processes for creating marketing materials.
- Access and manage the regulatory assets
Global Labeling Regulatory SME:
- Attend Global Labeling Committee (GLC) and Packaging and Labeling (PAL) meetings as the regulatory labeling SME.
- Conduct Label Change Request (LCR) reviews, understanding the correct usage of LCR vs. non-LCR and selecting appropriate evaluator groups.
- Maintain and update Global regulatory requirements labeling reference document.
- Ensure labeling practices comply with regulatory standards, performing impact and gap assessments for new or revised requirements.
UDI/Device Nomenclature Process Owner:
- Manage GS1, GUDID activities, including process improvements and remediations, as needed.
- Own and improve processes for medical device nomenclature processes (UDI, GMDN, etc.).
- Maintain account ownership for GS1, GTIN, UDI, and GMDN accounts for Align Technology, Inc.
Additional Support for Regulatory Compliance and Operations Activities:
- Assist with the review, remediation, and/or implementation of regulatory processes.
- Support the preparation and submission of regulatory documents for audit preparation.
- Participate in internal and external audits, providing necessary documentation and support.
- Collaborate with cross-functional teams to ensure regulatory compliance across all operations.
- Contribute to continuous improvement initiatives within the regulatory compliance and operations team.
- Provide training and support to team members on regulatory requirements and best practices.
- Maintain up-to-date knowledge of global regulatory standards and requirements.
What we're looking for
- Education: Minimum of a Bachelor’s degree in a technical or life sciences field.
- Experience: 4 to 6 years of experience in quality or regulatory roles in a regulated industry such as medical device or pharmaceuticals.
- Experience with medium and low-risk medical devices (Class II/I), SaMDs, and e-commerce products.
- Experience with project management is a plus.
- Orthodontic devices experience is a plus.
- Skills: Solid understanding and proven practices within both MDSAP regulations and ISO 13485: 2016 quality system management.
- Communication: Excellent presentation and communication skills both virtually and in-person.
- Teamwork: Ability to work both independently and collaboratively in a global team.
Complimentary skills
- Strong critical thinking and problem-solving abilities.
- Attention to detail.
- Excellent organizational skills.
- Proficiency in managing multiple tasks and prioritizing effectively.
- Expertise in labeling and labeling change assessments.
- Strong technical/computer skills.
- Outstanding written and verbal communication skills, with the ability to effectively communicate at multiple levels in the organization.
- Ability to collaborate across cross-functional teams.
- Independence and self-direction, with a strong desire to work collaboratively as part of a high-performing team.
- Adaptable and flexible in a fast-paced environment.
Pay Transparency
If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically.
For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S.
Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience.
Über Align Technology
Your 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:
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!
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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.
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.
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