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

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.

About the Role

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.

Responsibilities

• 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.
• 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.
• Evaluate the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
• 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.
• Verify and validate medical device instruction manuals and labeling.

Requirements

• 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.

Qualifications

• Must be able to manage multiple tasks and attention to detail.
• 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.
• The ability to be onsite, in the office as this is an essential function of the position (required).

Skills & Attributes

• Must be able to manage multiple tasks and attention to detail.
• 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.
• The ability to be onsite, in the office as this is an essential function of the position (required).

Benefits

• 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