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 authoring regulatory submissions (510k/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 file development).
  • Experience managing the activities and outputs of external consultants, paying particular attention to deadlines and agreed-to deliverables.
• Skills & Attributes:
  • Must be able to manage multiple tasks and attention to detail.
  • Demonstrated strong technical expertise in Americas medical device regulations, with preferred additional knowledge of international regulatory frameworks and clinical evaluation a plus.
  • Strong understanding and demonstrated ability to apply international regulatory standards to pertinent projects.
  • Effective communication and project management skills.
  • Excellent communication (verbal, written), interpersonal, and computer skills.
  • Well organized and flexible with handling multiple projects simultaneously in a highly matrixed environment while meeting established deadlines.
  • Someone who operates under minimal supervision with the ability to make decisions independently and assess when escalation is appropriate.
  • Demonstrated ability to be an effective contributor and leader in building a new organization, with a strong commitment to knowledge transfer and upskilling of others.
• The ability to be onsite, in the office as this is an essential function of the position (required)
• Authorization to work in the United States on a full-time, permanent, ongoing basis without the need for legal sponsorship now or in the future (required)

What’s In It For You

• A place for you to leave your comfort zone and grow beyond your potential (here, you’ll be encouraged to try new things and take risks!)
• Real responsibility from day 1, there’s no sitting on the sidelines at L’Oréal
• An environment where people of every ethnicity, social background, age, religion, gender and sexual orientation as well as people with disabilities are accepted, can speak up, will thrive and are celebrated!
• A place where you can contribute to something bigger! Many of our brands have societal /environmental causes to make concrete difference
• Base Salary Range: $126,900 - $184,000 (The actual compensation will depend on a variety of job-related factors which may include geographic location, work experience, education, and skill level) 
• Competitive Benefits Package (Medical, Dental, Vision, 401K, Pension Plan)
• Hybrid Work Policy (Up to 2 Days per week work from home for eligible roles, subject to manager approval)
• Flexible Time Off (Paid Company Holidays, Paid Vacation, Vacation Buy Program, Volunteer Time, Summer Fridays & More!)
• Access to Company Perks (VIP Access to L’Oréal’s Internal Shop for Discounted Products, Monthly Mobile Allowance)
• Learning and Development Opportunities (Unlimited Access to E-learnings, Lunch & Learn Sessions, Mentorship Programs, & More!)
• Employee Resource Groups (Think Tanks and Innovation Squads)
• Access to Mental Health & Wellness Programs

Don’t meet every single requirement? At L'Oréal, we are dedicated to building a diverse, inclusive, and innovative workplace. If you’re excited about this role but your past experience doesn’t align perfectly with the qualifications listed in the job description, we encourage you to apply anyways! You may just be the right candidate for this or other roles!

We are an Equal Opportunity Employer and take pride in a diverse environment. We’re committed to guaranteeing inclusive recruitment processes and advocating for hiring and promoting each candidate in an ethical and equitable way. The Group strictly prohibits discrimination against any applicant for employment because of the individual’s gender identity or expression, sexual orientation, visible and/or invisible disabilities, socio-economic and/or multicultural origins, health conditions, age, religion, or any other characteristics protected by law.