Director, Regulatory Affairs & Quality Assurance APAC

Summary

Join STERIS as the Director of Regulatory Affairs & Quality Assurance, APAC and drive regulatory excellence across APAC. In this pivotal role, you’ll shape and execute regional compliance strategies to ensure timely product registrations, labelling compliance, and change evaluations. You’ll oversee regulatory operations, mentor and develop a high-performing team, and ensure alignment with global standards and country-specific requirements (TGA, HSA, and more). With responsibility for annual operating plans and succession planning, you’ll shape the future of regulatory excellence while enabling life-saving technologies to reach patients across APAC.

What You Will Do

• Develops and implements regulatory strategies to support the growth of STERIS businesses in both Healthcare and Life Sciences business units. Builds relationships with business unit management in each area to define priorities for implementation of regulatory strategies aligned with key business unit initiatives.
• Actively engages with Senior Regulatory and Compliance management in developing strategic goals and initiatives to respond to an ever-changing regulatory compliance landscape, ensuring consistency in execution of strategies across all STERIS facilities.
• Provides Regulatory senior management and business unit leaders with timely and expert regulatory guidance regarding new or emerging regulations and integrates this information into the business unit plans and priorities.
• Partner with diverse functional areas within the company in striving for continuous improvement by analyzing new or alternative ways to improve systems, incorporating staff suggestions after analysis; responding to regulatory charges and utilizing various findings for the benefit of the organization. Leads the execution of revised processes and policies and works in tandem with Quality/Compliance management to train Regulatory, Compliance and facility Quality staff in revised processes and procedures.
• Provides input to the Sr. Director, Regulatory Affairs and senior Regulatory team members in the development of corporate policies, procedures and practices to provide guidance to STERIS operations in meeting product approval, compliance and quality system requirements.  Actively participate in the development and implementation of best practices within the STERIS RA department.
• Monitors and directs assessment, planning, establishment and evaluation of the work accomplished by their assigned Regulatory staff and coordinates professional development through use of individual development plans.
• Serves as primary contact (in alignment with his/her Team) with government regulatory agencies for the  international regulatory bodies in assigned regions.
• Provides oversight and direction to Corporate Regulatory and Compliance staff in the development, enhancement and standardization of Corporate Quality & Regulatory Compliance processes and their implementation as Corporate policies and procedures; includes working with and developing strong relationships with key personnel in other critical areas of the organization to develop sound policies and procedures.
• Provides regulatory guidance and leadership to new product development teams to assure timely submission of product approval applications in both domestic and international markets and obtain approvals in a timely manner in accord with business objectives.  Review and approve submissions prepared by regulatory staff to assure their quality and conformance with requirements
• Leads the development, issuance and publication/distribution processes for all STERIS Corporation Safety Data Sheets in compliance with Global Harmonization Standards.
• Reviews, advises or consults on, and approves product labeling and marketing literature materials to ensure that all product claims, promotion and instruction for use are appropriate, consistent with design, data and documentation, and comply with regulations. Monitors and evaluates product modifications and impact assessments on existing product registrations and provides guidance and action plans for addressing product modifications the Product Evaluation Chairperson.
• Works closely with site Quality management and Corporate functional management and provides direction to STERIS facilities in compliance audits such as those conducted under the Medical Device Single Audit Program (MDSAP), ensures remediation actions are immediately addressed with a corrective action plans followed by a comprehensive assessment to identify and correct systemic findings.

The Experience, Skills and Abilities Needed

• Significant years of experience in regulatory affairs, legal or government compliance, quality systems, internal auditing, applicable scientific, technical or clinical functions and/or healthcare industry experience
• Demonstrated ability to lead, motivate, train and develop a high performance team
• Demonstrated experience in effectively leading cross-functional teams
• Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
• Self-started with demonstrated organization, project management, time management and problem solving skills
• Ability to operate independently with minimal direct supervision and interacts daily with management from numerous functional areas.

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