RAQA Specialist

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 Australia and New Zealand. 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 of the Job

(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 submission and approval processes of TGA and Medsafe. 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.

May be required to support market access activities such as PL submission and

maintenance.

(20%) Regulatory Operations

To maintain a 12-month regulatory plans, renewals and new submissions

To participate in the annual registration budget exercise and track the monthly registration

expenses.

To maintain databases/ trackers of all submissions and approvals.

To support internal systems and processes, relating to regulatory and quality, e.g. International

Registration Requests (IRR), Change Notifications, PDM, SAP and GTS.

To 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.

(20%) 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

post-market registration issues.

To provide assessment of the new and changing regulations (both local and

international) for any impact. Outline the plan for mitigation of impact, communicate to

stakeholders and implement.

(10%) Regulatory Compliance

To assist in the copy review advertising and promotional materials and relevant internet

activities and publications to comply with all relevant internal policies and local country

regulations.

To help in the reporting of adverse event and field safety corrective action/ product recall

and to ensure timely closure with the regulatory authority.

(10%) Quality

To support the team in managing Internal and External Audits.

To assist the team in managing suppliers and vendors affecting the Quality Management

System (QMS) and to ensure compliance with the local, regional and global procedures.

To help manage the SOP, WI and the overall QMS (Quality Management System)

of the organization.

Guiding Principles (i.e. KSAs)

The incumbent will be required to demonstrate behaviour in accordance with Zimmer Biomet's Values, as listed below;

Respect the contributions and perspectives of all Team Members.

We respect you for your individual contributions and your diverse perspectives. We support your professional

growth and provide you with opportunities to share in the company's success.

Commit to the highest standards of patient safety, quality and integrity.

We commit to the highest standards of patient safety and quality in our products and services and to worldclass

integrity and ethical business practices.

Focus our resources in areas where we will make a difference.

We focus our resources in areas where we will make the greatest impact for our customers and patients

through our collective knowledge of the disease state or market, established infrastructure, relevant

engineering expertise and skillsets.

Ensure the company's return is equivalent to the value we provide our customers and patients.

We innovate to provide value through effective and efficient solutions for customers and improved outcomes

for patients to ensure the company's return is equivalent to the value we provide our customers and patients.

Give back to our communities and people in need.

We partner with communities where we live and work and support causes and programs that forward our

mission for people in need.

Education/ Experience Requirements.

Degree or tertiary qualifications in life sciences or Engineering.

Minimum 3year experience in Australian and New Zealand Regulatory requirements for medical devices

Problem solving skills applicable to complex regulatory, quality and safety issues

Excellent communication, planning and organizational skills

Ability to work well in cross functional team environment

Strong attention to detail

Ability to work well under pressure

Excellent computer skills in Microsoft Word, Excel, SharePoint, Power Point, Project

Demonstrated database proficiency

Strong Presentation skills preferred