Position Title: Principal Scientist, Medical Device Expert
Location: Clark, New Jersey (Hybrid)
Department: Research & Innovation Safety Evaluation, Regulatory Affairs and Claims Substantiation & Microbiology Division (SRCM)
For more than one hundred years, L’Oréal believes that beauty needs Science. In a world now transformed by digital technology and the emergence of new scientific domains, we are confident in our ability to turn these opportunities into major innovations, closely linked to the new consumer expectations all over the world. Science & Technology are allowing us to invent safe, trustable, sustainable & responsible beauty products and experiences that will change people’s lives.
L’Oréal Research & Innovation (R&I) has continuously invested upstream in its research with a high level of ambition. Our 4,100 L'Oréal R&I people are talented and highly skilled, located in major markets, working in a cooperative way, open to the world. L’Oréal, Research & Innovation is a vast, multidisciplinary, scientific community working in more than 30 specialized fields, spread out across the world in 21 research centers across 6 regional hubs, 14 evaluation centers, and 49 scientific and regulatory departments. Our employees represent over 60 nationalities and are united for one passion: to invent and perfect innovative, high-performance products for the well-being of all across the world.
To discover more on our scientific and technical functions at L'Oréal Research & Innovation, please check out our website
We are seeking an Principal Scientist, Medical Device Expert to join our Safety Evaluation, Regulatory Affairs and Claims Substantiation & Microbiology Division (SRCM) team in our Clark, New Jersey Research facility. This position is responsible for implementing and supporting the strategy related to the safety, claim substantiation, and regulatory compliance in target countries for the development, marketing, and distribution of medical device.
As an Principal Scientist, Medical Device Expert, your main responsibilities are:
- Provide critical interface with Asia Pacific and European hubs on safety, claims, and regulatory aspects for medical device project development.
- Provide input and technical guidance on safety, claims, and global regulatory requirements of medical devices to product development teams and acquisition or licensing projects
- 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.
- Define the recommended path to approval and regulatory requirements for product development teams and actively manage according to development timelines and defined strategies.
- Provide strong scientific guidance and representation to marketing and product development teams to enable compliant products that are commercially successful.
- 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.
- In close collaboration with the Regulatory Intelligence department, monitor and analyze regulatory developments worldwide 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.
- 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.
- Verify and validate medical device instruction manuals and labeling
To Succeed in this Position, You Have:
- MS or PhD degree in a technical discipline, preferably in 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 preferred, particularly for skin treatment and with over-the-counter products
- Demonstrated success in authoring regulatory submissions (510k/De Novo) 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).
- Must be able to manage multiple tasks and attention to detail.
- Strong technical expertise in the field of medical device clinical evaluation and regulation.
- Experience managing the activities and outputs of external consultants, paying particular attention to deadlines and agreed-to deliverables.
- Strong understanding and demonstrated ability to apply international regulatory standards to pertinent projects.
- Effective communication and project management skills.
- 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)
To Succeed in this Position, You Are:
- Someone with 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
What's In It For You:
- Corporate Short-Term Incentives (Corporate Profit-Sharing Bonus, Individual Performance Bonuses based on level)
- Competitive Benefit 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)
- Learning & 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 do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.
If you require a reasonable accommodation to complete an application for a recognized disability under applicable law, please email [email protected]. Please note this email will only respond to specific requests for assistance completing the application as a request for accommodation for a disability. All others will not be considered.
Our Safe Together Plan: Your safety is our highest priority. We will proceed with caution and adhere to enhanced protection standards to ensure our sites are safe for all employees. We must all operate with the shared responsibility for each other’s health & safety in mind.