Product Integrity Scientist

Position Summary: The Product Integrity Scientist will support product safety/integrity related to regulatory affairs for product development, raw materials or finished products. They will provide product integrity support for Swiss American Contract Development and Manufacturing (SA). The person in this role will support sound product safety strategy and follow-through implementation for product, finished good and product compliance in different skin health categories across global regions. As the product integrity personnel in the organization, this role is responsible for supporting product safety and compliance.

Essential Duties and Responsibilities:

• Responsible for managing product safety and compliance intelligence, policies, and programs of diverse scope across the business for raw materials, bulk products, finished and commercialized goods
• Responsible for creation of cosmetic ingredient declaration, quantitative and qualitative formulas
• Review and assess changes to safety and global regulatory requirements and industry best practices and facilitate implementation through new or revised processes.
• Responsible for evaluating and assessing safety and regulatory compliance of raw materials used at SA
• Responsible for safety and regulatory documentation for compliance requested by clients on SA formulations
• Responsible for safety assessments and compliance evaluations for skincare, OTC and medical device products across global regions including but not limited to prop 65, impurities, EU allergens etc.
• Responsible for working with other employees to ensure adherence to compliance of products, resolve compliance issues, as appropriate, and communicate as required to clients.
• Develop, plan, oversee and generate clinical, in vitro, in silico studies, and/or technical reviews which will insure the efficacy and safety of Swiss American products or Swiss American contracted formulations
• Expertise in methodologies used to assess the safety and efficacy of OTC, cosmetic and medical devices
• Manage client meetings and responses for ingredient and regulatory compliance
• Responsible for owning and maintaining current formulation system (Formulator Pro) to manage ingredient entry, ingredient compliance etc.
• Oversee the creation and/or maintenance of technical files as necessary to obtain and sustain product approval.
• Determine and communicate submission and approval requirements early in the product lifecycle to assure that projects plans are aligned to meet safety and regulatory guidelines.
• Participate in multidisciplinary project teams with the Client.
• Responsible for RID product safety compliance metrics for Quality Management Reviews.
• Responsible for SA quarterly newsletter on compliance based on research and interpretation of compliance guidelines
• Other duties may be assigned.