Ra/qa Director Apac

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.

Position Summary:

The mission of the STERIS Regulatory Affairs function is to implement efficient and effective processes to initially obtain and then maintain clearance to market STERIS products in support of STERIS's global business plans.

This includes determining registration and/or submission requirements in the US and international markets and working with product acquisition or development teams to ensure these requirements are met.

This group also identifies and supports Quality and Regulatory Compliance needs.

The Director Regulatory Affairs will have expert working knowledge of the following:

• 21 CFR Part 820
• Medical Device Quality System Regulations (QSR)
• ISO 13485: Medical devices
• Quality management systems
• ISO 9001: Quality management systems
• ISO 14971: Application of Risk Management to Medical Devices
• 21 CFR Part 80 Medical Device Reporting
• 21 CFR Part 80 Medical Device Corrections and Removals
• 21 CFR Part Enforcement Policy, Subpart C Recalls
• 21 CFR Part 1 Electronic Records, Electronic Signatures
• Global Harmonization Standard for Labeling
• TGA (Australia) Medical Device Regulations
• HSA (Singapore) Medical Device Regulations
• Other applicable country specific International Regulations

In addition, the Regulatory Affairs Director is well versed in current and pending changes in the international regulatory landscape its global influences on STERIS businesses.

He/she is expected to have in-depth, expert-level knowledge of the specific guidance, standards, and regulations applicable to numerous product types, technologies, and regulatory authority areas.

These activities require close work with STERIS Corporate domestic and international staff, significant interaction with business and Quality partners, and will include frequent interactions with government authorities.

Duties:

The Director Regulatory Affairs is a member of the department leadership providing regulatory guidance and strategic advice to the Sr.

Director, Regulatory Affairs and other leadership staff in regard to both domestic and international regulatory matters.

The managerial responsibilities of the Director include continuous support and review of product development, clearance, and acquisition work, support for current products including change evaluation and compliant product labeling and promotion, and effective management of their functional areas.

He/she is responsible for assessment, planning, accomplishment and evaluation of the work of the Regulatory Affairs group, and for the staff's professional development through use of individual development plans, training, mentoring, and performance evaluation.

The Director provides input to the long-term succession planning process for the department.

The Director is responsible for preparing the annual operating plan for his/her assigned area and executing the departmental objectives in line with the approved operating expenses.

• 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 everchanging 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.
• Uses his/her influence and experience as a Regulatory professional to 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 Regulatory Affairs department.
• The Director Regulatory Affairs monitors and directs assessment, planning, establis

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