At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.  

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards.  We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

 

Job Summary

Responsible for managing all facets of regulatory support to all Zimmer Biomet segments products. This includes developing regulatory submissions, managing departmental projects, creating and reviewing labelling, providing guidance and consultation for regulations and interacting with government authorities in Indonesia and Export Markets. 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 is required.

 

Principal Duties and Responsibilities

%

 

 

40

 

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

To define and implement product registration approval strategies and plans.To manage product approval process and responsible for clearing approval and other barriers to ensure timely market release of new products with appropriate licenses.To update significant and comprehensive commentary report on a monthly, quarterly and yearly basis.

40

 

Regulatory Operations

To maintain a 12-month regulatory plans, renewals and new submissionsTo maintain databases of all submissions and approvals.To support internal systems and processes, relating to regulatory and quality, e.g. GRP, GSP, Change Notifications, SAP, GTSTo 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.

5

 

Regulatory Compliance

To oversee copy review advertising and promotional materials and relevant internet activities and publications to comply with all relevant internal policies and local country regulations. Responsible for adverse event and field safety corrective action/ product recall reporting and timely closure with the regulatory authority.To manage the implementation of QMS such as Good Distribution Practices for Medical Device (GDPMD), ISO 9001, ISO 13485

5

 

New and Changing Regulatory Environment

To 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 postmarket registration issues.To provide assessment of the new and changing regulations for any impact. Outline the plan for mitigation of impact, communicate to stakeholders and implement.

10

 

Quality

To manage Internal and External Audits such as Authority or CAB (Conformity Assessment Body).Assist QA in the management of product complaints and execution of field safety correction action and related activities.To manage the SOP, WI and the overall QMS (Quality Management System) of theorganization.Other duties assigned by the immediate Manager.

 

100

 

Total Percent (not to exceed 100%)

 

Expected Areas of Competence (i.e. KSAs)

 

Good written spoken and written English abilitySuperior interpersonal and communication skillResponsible, professional, detail oriented and with patienceHighly organized and efficient individual.Able to work well in a team

 

Education/ Experience Requirements

Bachelor’s Degree in life sciences, technical (engineering) or related field; advanced degree strongly preferredMinimum of 2 years of experience required in a Regulatory Affairs capacityExperience in the areas of drugs, biologics, and combination products regulations is strongly preferredA combination of education and experience may be considered.Strong computer literacy including sound knowledge of the MS Office software and MS Excel

 

Travel Requirements

Up to 5%
What You Can Expect How You'll Create Impact What Makes You Stand Out Your Background Travel Expectations

EOE/M/F/Vet/Disability