About The Role We are seeking a detail-oriented and proactive Regulatory Affairs Advanced Specialist to join our Regulatory Affairs team. This position plays a critical role in ensuring the compliance of accompanying product labeling and promotional materials with global regulatory requirements. You will act as a key advisor to Marketing and Product teams and will provide strategic regulatory guidance to enable compliant and compelling product communication and to contribute to the development of innovative technology solution driving.

Key Responsibilities

• Serve as the primary regulatory advisor for all accompanying product labeling, advertising, and promotional materials developed by the global team to ensure compliance with applicable medical device health regulations.
• Collaborate closely with Marketing, Legal, and Medical Affairs to support the development and approval of compliant marketing campaigns and product claims.
• Interpret and apply US FDA regulatory requirements and coordinate with other regulatory team members for the rest of the word, to ensure compliant communication and labeling for medical devices and consumer health products.
• Participate in cross functional teams to assure appropriate requirements related to regulatory label review (i.e. intended use, instructions for use, user population) are defined for the specific project.
• Maintain and update labeling and promotional material SOPs and workflows as needed.
• Monitor changes in relevant global regulations and guidance impacting product labeling and promotion; provide training and updates to stakeholders. Additionally, monitor regulatory enforcement actions related to advertising for medical device and consumer products.
• Support labeling-related documentation for regulatory submissions and audits, as required.
• Provide regulatory input during product development, launch planning, and lifecycle management with a focus on labeling strategy and claims substantiation.

Qualifications And Experience

• Bachelor's degree in a scientific or healthcare-related field (Life Sciences, Pharmacy, Regulatory Affairs, etc.)
• 3+ years of experience in regulatory affairs, preferably with a focus on labeling or promotional review in the medical device or consumer healthcare industry.
• Solid understanding of FDA, EU, and/or international regulatory requirements for product labeling, advertising, and promotion.
• Strong attention to detail and critical thinking skills.
• Excellent communication and collaboration skills, with the ability to partner effectively across functions.
• Experience working in cross-functional environments and navigating competing priorities. Experience in a multi-regional/global role is a plus.
• RAC certification or coursework in regulatory affairs is a plus.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!