Job Description

Job Summary

This position will be responsible for managing all facets of regulatory support to all Zimmer Biomet segments products which includes developing regulatory submissions, managing departmental projects, reviewing labelling and HCP materials, providing guidance and consultation for regulations and interacting with government authorities in Malaysia and in other Export Markets. An understanding of Zimmer Biomet products and their use as well as an understanding of the regulations and their application is required.

Principal Duties and Responsibilities

• Work closely with regional RA & Global to drive reduction of registration cycle time through Speed to Market initiatives.

• Define and implement countries regulatory strategy, plan and budget.
• Manage and track Speed to Market performance for Malaysia and other Export Markets.
• Update significant and comprehensive commentary report on a monthly, quarterly and yearly basis.
• Understand and help influence Malaysia medical device regulatory environments by leveraging key relationships with the Authority and with industry groups.
• 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.
• Oversee copy review process implementation which includes advertising and promotional materials and relevant internet activities and publications to comply with all relevant internal policies and local country regulations.
• Coordinate with Regional RA director on Quality field actions & post-market requirements.
• Manage the implementation of GDPMD in the country.
• Manage the External Audits such as CAB (Conformity Assessment Body.
• Manage the Internal Audits and train the internal auditors.
• Manage the SOP, WI and the overall QMS (Quality Management System) of the organization.

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

• Good written spoken and written English ability
• Superior interpersonal and communication skill
• Responsible, professional, detail oriented and with patience
• Strong computer skills

Education/Experience Requirements

• Bachelor's Degree in life sciences, technical (engineering) or related field; advanced degree strongly preferred
• Minimum of 2 years of experience required in a Regulatory Affairs capacity
• Experience in the areas of medical devices, IVD or biologics regulations is strongly preferred.
• A combination of education and experience may be considered