Ra/Qa Associate

20 hours ago

Sydney, New South Wales, Australia Zimmer Biomet Full time

**Requisition Number**: APAC05094

**Employment Type**: Full-time

**Location**: Sydney

**RA / QA Associate**:
**About the Role**
- **Employment Type**: Full time permanent
- **Work Days**:Monday to Friday
- **Work Style**:Hybrid/Flex
- **Reporting Line**:RA/QA Manager
- **Location**: Belrose, Northern Beaches
- **Team Size**:3-5 other team members + larger global reg affairs team
- We are open to entry level regulatory affairs/quality associate applicants who can demonstrate experience within the Healthcare industry and familiarity or theoretical working knowledge of TGA/Medsafe authorities._

**Role Responsibilities**:
With an offering of products in the following surgical areas: Hip & Knee Arthroplasty, Spine, Extremities, Trauma, Sports Medicine and Surgical, the Zimmer Biomet Regulatory Affairs & Quality Specialist is responsible for:
Managing, coordinating and performing regulatory activities to ensure all RA documentation and approvals are current and up to date for all products supplied in ANZ (e.g. instruments, loan sets, implantable devices, third party products, etc.)

The role also requires involvement with ensuring post-market surveillance and regulatory reporting obligations are met in a timely manner.

As part of an amazing team, you will be responsible for your own portfolio, compiling and submitting registration dossiers for new products in Australia and NZ & managing communications with the TGA and Medsafe.

**About You**:

- You will have a tertiary qualification in Pharmacy/Life Science or Chemistry/ Engineering or similar field.
- Experience in working directly with regulatory agencies or similar demonstrated experience.
- Significant hands on experience with Class III Medical Devices/Conformity Assessment Submissions with TGA is desirable but not mandatory.
- The ability to work in a team environment, engage stakeholders within the business to achieve your desired outcome
- High level of attention to detail and excellent communication skills

In return, we offer a culture with a focus on performance, development & work/life balance, together with an attractive salary package and benefits.

**About Us**

As the leading innovator in musculoskeletal healthcare, our cutting edge robotics technology, interactive digital platforms, and comprehensive portfolio of products for joint reconstruction, bone and skeletal repair, sports and spinal injuries, help restore mobility, alleviate pain, and improve the quality of life for patients. Collaborating with top healthcare professionals around the globe to speed the pace of innovation, and expand the possibilities for successful treatment outcomes, Zimmer Biomet remains committed to our promise to look beyond what's possible now, and discover what's possible next.

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