Senior Technology Regulatory Compliance Analyst - Technology IT at Signant Health

• The Senior Technology Regulatory Compliance Analyst is responsible for ensuring compliance with global regulatory standards across Signant Health’s technology functions, including Enterprise IT, Cloud Operations, and R&D. Based in South Africa, this role provides leadership and expertise in regulatory compliance, focusing on systems and processes that support internally developed software products sold within the life sciences industry and Enterprise IT solutions. Reporting to the Associate Director of Regulatory Compliance, this position collaborates with cross-functional teams to build and maintain robust compliance frameworks.

Key Responsibilities:

Regulatory Compliance Oversight:

• Lead compliance efforts for technology functions to ensure adherence to global regulatory standards, including FDA 21 CFR Part 11, GAMP 5, ICH GCP, and EMA guidelines.
• Develop, implement, and maintain compliance frameworks for Enterprise IT, Cloud Operations, and R&D.
• Provide expert advice on regulatory requirements during the development and deployment of software products.
• Ensure software products meet global regulatory requirements applicable to the life sciences industry.

Audit and Risk Management:

• Plan and lead internal audits of IT systems and processes to assess compliance readiness.
• Support external audits and inspections by regulatory authorities and customers.
• Conduct risk assessments, identify potential compliance gaps, and oversee the implementation of mitigation strategies.

Policy and Documentation Management:

• Develop, review, and update policies, SOPs, and other documentation to align with regulatory requirements.
• Ensure validation and verification processes for IT systems and software are adequately documented and maintained.

Collaboration and Cross-Functional Engagement:

• Collaborate with Enterprise IT, Cloud Operations, and R&D teams to embed compliance into system design, software development, and operations.
• Act as a liaison with external stakeholders, including auditors and regulatory bodies, to address compliance-related queries.

Training and Mentorship:

• Design and deliver training programs on regulatory compliance requirements for technology teams in India.
• Mentor and guide junior analysts to ensure consistent application of compliance principles.

Continuous Improvement:

• Drive continuous improvement initiatives to enhance compliance processes and frameworks across technology functions.
• Stay updated on emerging trends and regulatory changes impacting the life sciences and software development industries.

Qualifications:

Education:

• Bachelor’s degree in Information Technology, Computer Science, Regulatory Affairs, or a related field.
• Advanced degree or certifications (e.g., RAC, CRCP, or equivalent) preferred.

Experience:

• 5-10 years of experience in IT regulatory compliance, particularly in life sciences or software development.
• Strong experience with global regulatory frameworks, including FDA 21 CFR Part 11, GAMP 5, and ICH GCP.

Skills and Competencies:

• Comprehensive understanding of IT systems, cloud operations, and software development lifecycle (SDLC).
• Proven ability to manage audits and regulatory inspections with strong problem-solving skills.
• Excellent project management, communication, and leadership abilities.
• Experience in working with geographically dispersed teams and global stakeholders.

Preferred Qualifications:

• Familiarity with Agile and DevOps methodologies.
• Experience with compliance in cloud-based environments and data security standards.