Sr. Regulatory Specialist, Ads, Promos & Labeling

Department: Quality

Location: US-North Carolina-Raleigh

Description

This position is ideal for mid-level regulatory professionals to join the Regulatory Operations and Compliance team as a Sr. Regulatory Specialist, 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.
  
  

Complementary 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.
  
  

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Global Diversity Statement

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.

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.