Principal Scientist, Medical Device Expert, L'Oreal Research & Innovation
L'Oréal, Clark, NJ, United States
Principal Scientist, Medical Device Expert, Research & Innovation, Safety Evaluation, Regulatory Affairs and Claims Substantiation & Microbiology (SRCM)
Location: Clark, New Jersey (Hybrid)
Position Overview 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
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 contribute 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 develop 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.
Qualifications
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.
Additional Requirements:
Ability to work 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).
Benefits
A place for you to leave your comfort zone and grow beyond your potential.
Real responsibility from day 1, no sitting on the sidelines.
An inclusive environment where people of every background can thrive.
A place where you can contribute to something bigger.
Base Salary Range: $126,900 - $184,000.
Competitive benefits package (Medical, Dental, Vision, 401K, Pension Plan).
Hybrid work policy (up to 2 days per week work from home).
Flexible time off (paid holidays, vacation, volunteer time).
Access to company perks, such as monthly mobile allowance and internal shop discounts.
Learning and development opportunities (e‑learning, lunch & learn, mentorship).
Employee resource groups.
Access to mental health & wellness programs.
Equal Opportunity Employer 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.
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Position Overview 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
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 contribute 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 develop 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.
Qualifications
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.
Additional Requirements:
Ability to work 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).
Benefits
A place for you to leave your comfort zone and grow beyond your potential.
Real responsibility from day 1, no sitting on the sidelines.
An inclusive environment where people of every background can thrive.
A place where you can contribute to something bigger.
Base Salary Range: $126,900 - $184,000.
Competitive benefits package (Medical, Dental, Vision, 401K, Pension Plan).
Hybrid work policy (up to 2 days per week work from home).
Flexible time off (paid holidays, vacation, volunteer time).
Access to company perks, such as monthly mobile allowance and internal shop discounts.
Learning and development opportunities (e‑learning, lunch & learn, mentorship).
Employee resource groups.
Access to mental health & wellness programs.
Equal Opportunity Employer 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.
#J-18808-Ljbffr