Principal Scientist, Medical Device Expert, L'Oreal Research & Innovation

Principal Scientist, Medical Device Expert

Research & Innovation, Safety Evaluation, Regulatory Affairs and Claims Substantiation & Microbiology (SRCM) - Clark, New Jersey (Hybrid)

L’Oréal, the world’s #1 beauty company, invites applicants to join our Research & Innovation team in Clark, New Jersey. Our 4,100 experts leverage science and technology to invent safe, sustainable beauty products.

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.

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 participate 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.

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.

• MS or PhD degree in a technical discipline, preferably pharmacy, medicine, or bioengineering.

• 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 authoring regulatory submissions (510(k)/De Novo and eventually PMA) through regulatory clearance and/or approvals.
• Good working knowledge of QSR within product development, manufacturing, and post-market.
• International product registration experience highly desired (Technical…