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SRG is a Global Life Sciences staffing and consulting firm and we are seeking a Regulatory Affairs Specialist for a 7 month contract. This is a remote position.
• Accountable to ensure all elements of Global Regulatory Affairs are considered during the Supply Chain Digital Transformation requirement gathering, system design, and implementation.
• Ensures existing regulatory affairs system interfaces are identified and designed appropriately into the new solution(s). Consider global activities and requirements.
• Liaison with the global regulatory affairs team to ensure current standards are well understood and integrated into the duration of Digital Transformation.
• Develops standardized system approaches aligned with industry best practices in regulatory affairs.
• Supports the creation of systems and tools to add global efficiency and data sharing as a result of the Digital Transformation.
• Maintains comprehensive knowledge of applicable regulatory requirements and interpretation.
• Provides regulatory compliance expertise by sharing external regulatory environment, industry trends as well recommending actions to address any potential impact to the enterprise.
• A minimum of 5 years developing and deploying, efficient and effective regulatory affairs processes and automation, preferably across multiple geographic regions.
• Experience in an organization with regulatory affairs as a compliance function. Experience with company controls for global regulatory submissions and associated data. Experience with a Regulatory Information Management system (RIM) and Document management System required.
• Demonstrated understanding of Medical Devices, Consumer Products, and Cosmetic regulations across the globe.
• A Bachelor’s degree in Sciences, Engineering, or equivalent degree.
• 8+ years of experience in a regulatory affairs role in a medical device, pharmaceutical, cosmetic or similar environment.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.