Dermalogica
Regulatory Director for Medical Tools and Products
Dermalogica, Carson, California, us, 90749
Regulatory Director for Medical Tools and Products Pay Competitive
Increase your chances of an interview by reading the following overview of this role before making an application. Location Carson/California Employment type Full-Time Job Description
Req#: 2525909 We are seeking a talented and experienced
Regulatory Director for Medical Tools and Products
to join our team. In this new role, you will play a crucial role in overseeing all regulatory affairs related to the development, registration, and compliance of medical tools or skincare products for use in the treatment room. Your expertise will ensure that our products meet the highest regulatory standards while providing strategic guidance on compliance and product development strategies. You will collaborate closely with cross-functional teams, including R&D (internal or external), Quality Assurance, Marketing, and Legal, to ensure seamless regulatory compliance throughout the product lifecycle. Key Responsibilities: Regulatory Compliance:
Stay up-to-date with global regulations, standards, and guidelines governing medical tools and skincare products. Interpret and apply these regulations to the organization's products and operations. Develop and implement strategies to ensure compliance with applicable regulatory requirements. Product Registration:
Lead and oversee the preparation, submission, and maintenance of regulatory filings for medical devices used in skincare. This includes preparing and reviewing documentation such as pre-market notifications, 510(k) submissions, technical files, and design dossiers. Liaise with regulatory agencies to facilitate timely approvals. Quality Management System:
In partnership with Quality Assurance, ensure robust quality management systems to comply with applicable regulations and standards, including procedures, policies, and controls to support product development, manufacturing, testing, and post-market surveillance activities. Cross-functional Collaboration:
Collaborate with R&D (internal and external), Quality Assurance, Marketing, and Legal, to provide regulatory guidance and support throughout the product lifecycle. Act as a regulatory subject matter expert and advise on regulatory requirements for new product development, labeling, advertising, and promotional materials. Regulatory Intelligence:
Monitor and analyze regulatory trends, changes, and developments in the medical device and skincare industries. Assess potential impact on the organization's products and provide recommendations to senior management. Proactively identify regulatory risks and develop mitigation strategies. Compliance Audits and Inspections:
In partnership with Quality Assurance, prepare for and manage regulatory audits and inspections conducted by regulatory authorities or notified bodies. Ensure readiness by maintaining comprehensive documentation, addressing any findings or non-compliance issues, and implementing corrective and preventive actions. Risk Management:
Implement risk management processes to identify, assess, and mitigate potential risks associated with launch of medical tools and products. Stay informed about emerging safety concerns and drive appropriate actions to maintain product safety and effectiveness. Training and Education:
Provide regulatory training and education to internal stakeholders, ensuring a strong understanding of regulatory requirements and their impact on product development, commercialization, and post-market activities. Foster a culture of compliance throughout the organization.
Qualifications: Bachelor's or advanced degree in a relevant scientific discipline, engineering, or a related field. Experience (typically 5+ years) in regulatory affairs within the medical device industry, with a focus on skincare or dermatology. In-depth knowledge of global medical device regulations, such as FDA (US), EU MDR, Health Canada, and other relevant standards. Proven track record of successful product registrations and regulatory approvals for medical devices in skincare or cosmetic dermatology preferred. Understanding of key requirements including ISO 13485, ISO 14155:2011 and ISO 10993. Experience in leading and managing regulatory audits and inspections. Regulatory certifications or memberships (e.g., RAC) are desirable but not essential. Key Skills: Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Strategic thinking and problem-solving abilities, with a proactive and results-oriented approach. Detail-oriented with strong analytical and organizational skills. Why Join Dermalogica? Competitive base salary range of $120,000-140,000; exact base salary determined by various factors including experience, skills, education, geographic location, and budget. Eligible for participation in the discretionary company bonus plan, based on personal performance and company results. Comprehensive health benefits package, including life/accident/disability insurance, wellness programs, paid family leave, domestic partner benefits, education/training programs, monthly product allowances, annual fitness reimbursement, and 401(k) matching. A vibrant company culture that fosters personal well-being, creativity, and integrity. Be part of a global brand that is revolutionizing the skincare industry. Join our team as the
Regulatory Director for Medical Tools and Products
and contribute to the development of cutting-edge products that make a difference in the lives of our customers. Apply now and be part of our passionate and forward-thinking organization! All applications will be reviewed for consideration, and if your skills and experience align with the position, a member of our team will contact you. Dermalogica is an equal opportunity employer that embraces diversity, equity, and inclusion. #LI-LR1 #LI-Hybrid About the company Dermalogica is an American personal care company headquartered in Carson, California. Notice Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
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Increase your chances of an interview by reading the following overview of this role before making an application. Location Carson/California Employment type Full-Time Job Description
Req#: 2525909 We are seeking a talented and experienced
Regulatory Director for Medical Tools and Products
to join our team. In this new role, you will play a crucial role in overseeing all regulatory affairs related to the development, registration, and compliance of medical tools or skincare products for use in the treatment room. Your expertise will ensure that our products meet the highest regulatory standards while providing strategic guidance on compliance and product development strategies. You will collaborate closely with cross-functional teams, including R&D (internal or external), Quality Assurance, Marketing, and Legal, to ensure seamless regulatory compliance throughout the product lifecycle. Key Responsibilities: Regulatory Compliance:
Stay up-to-date with global regulations, standards, and guidelines governing medical tools and skincare products. Interpret and apply these regulations to the organization's products and operations. Develop and implement strategies to ensure compliance with applicable regulatory requirements. Product Registration:
Lead and oversee the preparation, submission, and maintenance of regulatory filings for medical devices used in skincare. This includes preparing and reviewing documentation such as pre-market notifications, 510(k) submissions, technical files, and design dossiers. Liaise with regulatory agencies to facilitate timely approvals. Quality Management System:
In partnership with Quality Assurance, ensure robust quality management systems to comply with applicable regulations and standards, including procedures, policies, and controls to support product development, manufacturing, testing, and post-market surveillance activities. Cross-functional Collaboration:
Collaborate with R&D (internal and external), Quality Assurance, Marketing, and Legal, to provide regulatory guidance and support throughout the product lifecycle. Act as a regulatory subject matter expert and advise on regulatory requirements for new product development, labeling, advertising, and promotional materials. Regulatory Intelligence:
Monitor and analyze regulatory trends, changes, and developments in the medical device and skincare industries. Assess potential impact on the organization's products and provide recommendations to senior management. Proactively identify regulatory risks and develop mitigation strategies. Compliance Audits and Inspections:
In partnership with Quality Assurance, prepare for and manage regulatory audits and inspections conducted by regulatory authorities or notified bodies. Ensure readiness by maintaining comprehensive documentation, addressing any findings or non-compliance issues, and implementing corrective and preventive actions. Risk Management:
Implement risk management processes to identify, assess, and mitigate potential risks associated with launch of medical tools and products. Stay informed about emerging safety concerns and drive appropriate actions to maintain product safety and effectiveness. Training and Education:
Provide regulatory training and education to internal stakeholders, ensuring a strong understanding of regulatory requirements and their impact on product development, commercialization, and post-market activities. Foster a culture of compliance throughout the organization.
Qualifications: Bachelor's or advanced degree in a relevant scientific discipline, engineering, or a related field. Experience (typically 5+ years) in regulatory affairs within the medical device industry, with a focus on skincare or dermatology. In-depth knowledge of global medical device regulations, such as FDA (US), EU MDR, Health Canada, and other relevant standards. Proven track record of successful product registrations and regulatory approvals for medical devices in skincare or cosmetic dermatology preferred. Understanding of key requirements including ISO 13485, ISO 14155:2011 and ISO 10993. Experience in leading and managing regulatory audits and inspections. Regulatory certifications or memberships (e.g., RAC) are desirable but not essential. Key Skills: Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Strategic thinking and problem-solving abilities, with a proactive and results-oriented approach. Detail-oriented with strong analytical and organizational skills. Why Join Dermalogica? Competitive base salary range of $120,000-140,000; exact base salary determined by various factors including experience, skills, education, geographic location, and budget. Eligible for participation in the discretionary company bonus plan, based on personal performance and company results. Comprehensive health benefits package, including life/accident/disability insurance, wellness programs, paid family leave, domestic partner benefits, education/training programs, monthly product allowances, annual fitness reimbursement, and 401(k) matching. A vibrant company culture that fosters personal well-being, creativity, and integrity. Be part of a global brand that is revolutionizing the skincare industry. Join our team as the
Regulatory Director for Medical Tools and Products
and contribute to the development of cutting-edge products that make a difference in the lives of our customers. Apply now and be part of our passionate and forward-thinking organization! All applications will be reviewed for consideration, and if your skills and experience align with the position, a member of our team will contact you. Dermalogica is an equal opportunity employer that embraces diversity, equity, and inclusion. #LI-LR1 #LI-Hybrid About the company Dermalogica is an American personal care company headquartered in Carson, California. Notice Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
#J-18808-Ljbffr