Leads business unit regulatory resources and shares the workload (hands on) to ensure timely product registrations, regulatory planning for new product introductions and product changes, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy
Exercises supervision in terms of budgets, schedules, methods, staffing and performance. Establishes operational objectives and work plans, and delegates assignments to subordinates.
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
Involved in developing, modifying and executing company regulatory policies that affect immediate operations.
Regularly interacts with senior management or executive levels on matters concerning several functional areas and/or customers.
Key Areas of Responsibility (KARs):
This position is responsible for managing a global regulatory team of Value Segment Solutions (VSS), which is composed of regulatory professionals located in China, US and Brazil.
Drives the message that we need to provide “quality” products which are safe and effective.
Responsible for product registrations/approvals.
Responsible for working with VSS Q&R Business Leader to prepare for compliance with new EU MDR.
Keep abreast of current regulatory procedures and changes. Participates in direct interaction with regulatory agencies on defined matters.
Recommend and develop strategies and create detailed written regulatory plans for:
Traditional, abbreviated or special 510(k)s
China CFDA domestic registrations
CE technical File
Worldwide product registrations
Responsible for the coordination and preparation of document packages 510(k) pre-market notification, technical file and design dossiers for CE marking, China CFDA domestic registrations and support worldwide product registrations per in-country regulations
Drives improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance
Provide guidance to business unit on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, EU MDR (moving forward), ISO 13485 and ISO 14155, Canadian CMDCAS, US FDA’s and China CFDA’s guidance documents & etc.
Responsible for ensuring compliance with the current MA&TC regulatory procedures and updating the procedures when new regulatory requirements become effective.
Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
Review and approve advertising, promotional items and labeling for regulatory compliance.
Coordinate testing required to support regulatory submissions.
Strengthen and build clinical & regulatory capabilities.
Develop talent and build up Regulatory as a value–added business partner.