The role will be responsible for managing all facets of regulatory and quality support to all Zimmer Biomet segments products and for ensuring regulatory. This includes leading a group of regulatory professionals, developing regulatory submissions, managing departmental projects, creating and reviewing labelling and promotional materials, providing guidance and consultation for regulations and interacting with government authorities in Thailand, Singapore, Malaysia, Vietnam and ASEAN Export Markets, as well as India, Pakistan, etc.

In the meantime, overseeing quality compliance to applicable global, regional and local QMS requirements, ensuring product quality and patient safety. An understanding of Zimmer Biomet products and their use as well as an understanding of the regulations, both pre-market and post-market and their application are required.

Principal Duties & Responsibilities

Regulatory Affairs

• Work closely with Regional, Country, and Global teams to drive new registrations and maintain registration for business continuity.
• Define and implement regulatory strategies and submission plans.
• Manage product approval process and responsible for clearing approval and other barriers to ensure timely market release of new products with appropriate licenses.
• Manage and track Speed to Market performance.
• Update significant and comprehensive commentary report on a monthly, quarterly and yearly basis.

Regulatory Operations

• Maintain a 12-month regulatory plans and registration budget for new submissions, renewals and field notifications.
• Maintain databases of all submissions and approvals.
• Support internal systems and processes, relating to regulatory and quality, e.g. International Registration Requests (IRR), Change Notifications, SAP, GTS
• Oversee and ensure development, implementation and compliance of relevant SOPs and execute regulatory operations such as Global Distribution Regulatory Controls and Regulatory Information Management System.

Regulatory Compliance

• Oversee copy review advertising and promotional materials and relevant internet activities and publications to comply with all relevant internal policies and local country regulations.
• Oversee the r adverse event and field safety corrective action/ product recall reporting and timely closure with the SEA regulatory authorities.
• Manage the SOP and WI related to internal and external regulatory compliance.
• Collaborate with QA team in managing the other areas of quality (e.g., labelling) that may result from new and changing regulatory landscape.
• Support global and local initiatives, product lifecycle project and audits.

New & Changing Regulatory Environment

• Understand and help influence medical device regulatory environments by leveraging key relationships with the Authority and with industry groups.
• Proactively work with the government officials and other agencies in resolving pre- and post-market registration issues.
• Provide assessment of the new and changing regulations for any impact. Outline the plan for mitigation of impact, communicate to stakeholders and implement.
• Monitor daily operations, supervision and mentoring a team of Regulatory Affairs Associate/Specialist and to provide direction to subordinates using established policies and procedures.
• Partner and work pro-actively with the SEA stakeholders and distributors to ensure the optimal regulatory strategy complying with the regulations of SEA countries.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence

• People management skills
• Good written spoken and written English ability.
• Superior interpersonal and communication skills
• Responsible, professional, detail oriented and with patience
• Highly organized and efficient individual
• Able to work well in a team.
• Strong computer skills.

Education / Experience Requirements

• Bachelor’s Degree in life sciences, technical (engineering) or related field; advanced degree strongly preferred.
• Minimum of 8 years of relevant Regulatory Affairs experience in the medical device industry.
• Working in quality system audit and compliance.
• A combination of education and experience may be considered

Travel Requirements

• Up to 50%; as and when required