Job Description
Principal Scientist, Medical Device Expert, Research & Innovation, Safety Evaluation, Regulatory Affairs and Claims Substantiation & Microbiology (SRCM) - Clark, New Jersey (Hybrid) Hello, we’re L’Oréal, we're not just building brands; we're shaping how the world experiences beauty (and it takes a lot of cool jobs to do it). Intrigued? Keep reading, this might be the opportunity you've been searching for. Who We Are Join us at L’Oréal, the world's #1 beauty company present in over 150 markets. For over a century, we have been transforming; fueled by data, tech, innovation, and science. Together, we tackle big challenges while making sure we stay committed to making the world a more inclusive and a better place for everyone & our planet. At L’Oréal Research & Innovation we are pushing the boundaries of Science & Tech. We invest heavily in cutting-edge research, leveraging advanced technologies to understand skin, hair, and microbiome, while discovering new active ingredients and launching outperforming formulas. Our 4,100 L'Oréal R&I experts leverage Science & Technology to invent safe, trustable, sustainable & responsible beauty products and experiences that will change people’s lives. We are seeking a Principal Scientist, Medical Device Expert to join our Safety Evaluation, Regulatory Affairs and Claims Substantiation & Microbiology (SRCM) team in our Clark, New Jersey Research facility. This position primarily leads and supports the Americas regulatory strategy for medical devices, partnering with internal safety and claims experts to ensure compliance and alignment with L’Oréal standards and applicable regulations across target countries for development, marketing, and distribution. A Day in the Life: As a Principal Scientist, Medical Device Expert, your main responsibilities will include: Global Interface & Guidance: Lead the Americas regulatory input for medical device projects, acting as a key interface with Asia Pacific and European hubs. Provide regional regulatory requirements and technical guidance to product development teams and to acquisition or licensing projects. Reporting Structure: This position will report directly into SVP SRCM Americas with dotted line to Global Director SRCM Medical Devices & Beauty Aesthetics. Regulatory Submissions: Support the regulatory notification and submission function. Responsible for assembly and obtaining all required regulatory clearances coupled with successful negotiations and interactions with domestic and foreign regulatory agencies on assigned projects. Approval Pathway & Management: Define the recommended path to approval and regulatory requirements for product development teams and actively manage according to development timelines and defined strategies. Scientific & Commercial Guidance: Provide strong scientific guidance and representation to marketing and product development teams to enable compliant products that are commercially successful. Data Assessment & Compliance: Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations. Assess the acceptability of data for submission filing to comply with applicable regulations. Regulatory Intelligence & Strategy: In close collaboration with the Regulatory Intelligence department, monitor Americas and analyze regulatory developments and perform impact analysis on medical device projects under development or to be developed. Evaluate the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions. Process Development & Training: Identify the need for new regulatory procedures, SOPs, and participates in development and implementation. Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance. Documentation Verification: Verify and validate medical device instruction manuals and labeling. We Are Looking For: To succeed in this position, you are a highly experienced and knowledgeable expert in medical devices, with a strong focus on regulatory affairs and claims. Education: MS or PhD degree in a technical discipline, preferably in pharmacy, medicine, or bioengineering. Experience 10+ years of experience in the project management of medical devices with specific focus on safety, claim, and regulatory aspects. Prior experience with energy-emitting therapeutic devices, substance based particularly for skin treatment and with over-the-counter and/or general wellness device products. Demonstrated success in