Senior Specialist, Global Regulatory Systems

Representative for the Global Regulatory System team. The individual will be responsible for providing leadership project management and training expertise to Regulatory Affairs team and cross-functional teams. Responsible for supporting the implementation adoption and utilization of the systems required to allow Global and Regional Regulatory Affairs to fulfil their responsibilities. Liaises with multiple functions of the business i.e. Regulatory Global and Site Quality Global Supply Chain Global and Local Marketing Legal Site Operations Clinical Affairs Medical Affairs R&D and IT to assist with ensuring that information and documentation required by the regional teams in global product registration activities is available at the point of need. Provides guidance and training to Regulatory Affairs team members on the use of the systems in support of global and regional regulatory activities. Develops documentation e.g. training materials / work instructions to support the use of the regulatory systems.

The Senior Specialist Global Regulatory Systems operates against the RA Mission Statement: PROTECT the Business; GROW the Business. This involves engaging as a trusted and strategic business partner delivering pragmatic solutions and creative regulatory strategies to:

• PROTECT the business and our freedom to operate.
• GROW the business and create real advantages for customers and wearers.

Supporting RIM or other systems:

• Supports the implementation and improvement of regulatory affairs processes including:

  • systems relating to the Regulatory Information Management (RIM) system

    • Cascades Vault RIM initiatives expectations and messaging to end users and capture questions & feedback advocates for best practices.

    • Acts as the Change Agent providing Technical and Training support for the Users.

    • Provide support to drive actions as per RIM Roadmap.

    • Fulfill the assigned tasks as certified Veeva Vault RIM Business Administrator as per company procedures in cooperation with IT.

  • the availability of technical documentation in support of global product submissions and registrations

  • the definition / updates of Source of Truth (SOT) information as per global procedures

  • and Unique Device Identification (UDI) management.

• Works with regional RA teams to identify and propose improvements to regulatory systems including how the system interfaces with other systems such as the eQMS.

• Works closely with the RIM system and other system administrator teams to support changes and improvements required.

• Liaises with other non-RA internal functions to assist with ensuring that all documentation required to support global product registration activities is adequately embedded in the QMS and is available in the RIM system for end users.

• Monitors the use of the RIM system supporting the regional teams with the completion of activities relating to global product registrations. Monitors the use of other regulatory systems as necessary.

• Supports the development of metrics relating to use and performance of the RIM system and other regulatory systems.

• Supports the investigation into issues identified with or through regulatory systems liaising across functions as required and utilizing QMS processes as appropriate.

• Maintains comprehensive audit-ready records of activities as required by the QMS.

Registration Activity supporting regional RA activities:

• May assist with preparation compilation and submitting regulatory documents for the registration of current and new products in assigned marketsas agreed with regional RA leadership.

• Interacts with Regulatory Affairs personnel at regulatory agencies consultants contract manufacturers and distributors to ensure requirements are understood and submissions are complete and accurate to avoid any potential delays in approval if needed.

• Works with in-country RA representatives to determine regulatory requirements for product registrations in responsible regions.

• Maintains up-to-date knowledge of global regional and national regulations guidelines and advisory documents required for marketing CooperVision products in a specified region.

• Communicates applicable regulatory requirements to CooperVision Regulatory Affairs management and business partners.

• Analyses impact and communicates with management changes in regulations or requirements that have been identified.

• Represents the perspective of regulatory affairs to the company.

• Act as a resource to the regions on regulatory / quality issues and propose changes to minimize risks and enhance quality reliability safety and productivity.

• Provides Training and support as needed.

• Other duties as assigned.

Monitoring Registration Requirements:

Support to CooperVision Processes:

CooperVisions management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

Travel:

Up to 10% local or international travel to CooperVision facilities government agencies customers trade shows or training courses.

Knowledge Skills and Abilities:

• Excellent written and verbal communication skills; able to convey messages in a logical and concise manner.

• Experience analyzing regulations and international standards required.

• Proven track record of implementing continuous improvement of regulatory and quality management system processes.

• Experience with change control and change management.

• Strong project management technical writing and analytical mathematical and computer skills.
• Strong problem-solving competency.
• Exceptional attention to detail with strong organizational skills.
• Independent self-starter; manages time effectively and completes tasks on-time with minimal supervision.
• Ability to work effectively in multinational/multicultural environments including adjust work schedule to adapt to different time zones as needed.
• Adapts quickly to changes in workload staffing and scheduling.

• Working knowledge of regional medical device regulations is required.

• Working knowledge of international regulations (eg. ISO 13485 ISO 14975 or others) is preferred.

• Veeva Vault Business Administrator certification to be gained.
• Language skills - Fluent command of spoken and written English and Chinese required.

• Proficient with Adobe Acrobat and Microsoft Office Suite especially Project Visio and Excel (including data manipulation and graphing).

Work Environment:

• Able to work long periods of time in a normal office environment while sitting and working on a computer.

• Sedentary to light physical effort necessary to perform the job.

Experience:

• 5 yearsof experience in the regulated medical device or pharmaceuticalindustries within the APAC region is preferred.
• Working knowledge of domestic and international regulations; ISO 13485 ISO 14975 AMDD and other regulations that affect Class II and III medical device compliance.
• Working knowledge of Regulatory Management Systems such as Veeva Vault RIM application streamlining regulatory processes.

• Experience in technical writing and evaluating manufacturing changes for impact on global regulatory affairs submissions.

• Experience in electronic document management systems and auditing.

Education:

• Bachelors degree in a scientific or technical discipline from a four-year college or university required.
• Advanced degree and Regulatory Affairs Certification desirable.