Director, Regulatory Affairs

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. 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 Develop and implement regulatory strategies to support the growth of STERIS businesses in both Healthcare and Life Sciences business units. Build relationships with business unit management in each area to define priorities for implementation of regulatory strategies aligned with key business unit initiatives. Actively engage 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. Provide Regulatory senior management and business unit leaders with timely and expert regulatory guidance regarding new or emerging regulations and integrate 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. Lead the execution of revised processes and policies and work in tandem with Quality/Compliance management to train Regulatory, Compliance and facility Quality staff in revised processes and procedures. Provide 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 Regulatory Affairs department. Monitor and direct assessment, planning, establishment and evaluation of the work accomplished by assigned Regulatory staff and coordinate professional development through use of individual development plans. Serve as primary contact (in alignment with the Team) with government regulatory agencies for the international regulatory bodies in assigned regions. Provide 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; include working with and developing strong relationships with key personnel in other critical areas of the organization to develop sound policies and procedures. Provide 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 ensure their quality and conformance with requirements. Lead the development, issuance and publication/distribution processes for all STERIS Corporation Safety Data Sheets in compliance with Global Harmonization Standards. Review, advise or consult on, and approve 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. Monitor and evaluate product modifications and impact assessments on existing product registrations and provide guidance and action plans for addressing product modifications to the Product Evaluation Chairperson. Work closely with site Quality management and Corporate functional management and provide direction to STERIS facilities in compliance audits such as those conducted under the Medical Device Single Audit Program (MDSAP), ensure remediation actions are immediately addressed with a corrective action plan 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 interact daily with management from numerous functional areas. STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17 000 associates and Customers in more than 100 countries. STERIS strives to be an Equal Opportunity Employer. #J-18808-Ljbffr