Associate Director Regulatory Compliance R&D at Signant Health

• In this role, you will play a pivotal role in defining and designing the R&D Quality Program, conducting assessments and audits, and facilitating communication with internal and external stakeholders. If you have a strong background in compliance management and a drive for continuous improvement, we want to hear from you!

Responsibilities:

Strategy and Planning

• Define the R&D Quality Program, ensuring adherence to quality, regulatory, legislative, and contractual requirements.
• Enhance existing compliance programs and processes to optimize effectiveness.
• Develop, review, and modify organizational policies, standard operating procedures (SOPs), and work instructions.
• Design and execute audit procedures to assess R&D compliance with policies, SOPs, and procedures.
• Stay updated on industry advancements to ensure organizational adaptation and compliance.

Compliance and Audit Assessments

• Manage compliance testing and monitoring of regulatory obligations, identifying potential risks and addressing them proactively.
• Conduct internal risk assessments and compliance audits to identify areas for improvement.
• Establish R&D audit procedures aligned with industry standards.
• Collaborate with the Legal, Regulatory, and Compliance team to execute and manage the implementation of ISO27001.
• Coordinate, attend, and represent R&D in third-party audits, addressing customer requests and findings to enhance audit readiness.

Communication

• Develop effective materials, trainings, and tools to communicate compliance requirements to R&D teams.
• Develop compliance policies, plans, and strategies aligned with laws, regulations, policies, and standards.
• Collect, analyze, and prepare reports for senior management, regulators, and relevant stakeholders.
• Collaborate with the Quality Team to ensure alignment with Signant's quality cadence.
• Work closely with global Compliance colleagues, business management, Legal, Credit Policy, IT, and other internal support functions.

Knowledge & Experience

• Experienced in a regulated environments, preferably in healthcare.
• Strong knowledge of legal and regulatory compliance standards.
• Experience in IT governance, risk, and compliance management.
• Strategic thinker with the ability to develop and implement multidimensional business plans.
• Skilled at driving execution of plans and tactics.

Personal Attributes

• Excellent written and oral communication skills, with experience presenting to senior management and stakeholders.
• Proven project management skills, handling projects from inception to completion.
• Take full responsibility for the compliance function within the R&D business.