Regulatory Affairs Lead

7 days ago

Sydney, Australia Zimmer Biomet Full time

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.

**What You Can Expect**:
You will be esponsible for ensuring OSSIS meets all its regulatory obligations which includes managing/ overseeing the validation and regulatory obligations for current and future OSSIS products and services in all markets. You will support the Quality Team to ensure OSSIS meets all its quality obligations in accordance with Zimmer Biomet’s relevant policies and applicable ISO standards.

**How You'll Create Impact**:

- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Provide responses to notified body and health authorities regarding product information or issues.
- Assist in establishing regulatory priorities or budgets and allocate resources and workloads for OSSIS.
- Develop a strong knowledge and understanding of ISO 13485, FDA, TGA and EU Medical Device Regulation, applicable regulations, guidance and standards applicable to company products.
- Develop and maintain a compliance strategy to align anticipated business changes with their related regulatory requirements.
- Develop a working relationship with local authorities to facilitate new product submissions and address queries to ensure medical device registrations are well positioned for approval.
- Prepare, review and file appropriate FDA, Europe, TGA and other, premarket submission to ensure devices are commercially available in those regions.: 510(K), pre-lDEs, IDEs, etc
- Perform other RA pertinent duties as requested

**What Makes You Stand Out**:

- 5 years of quality/regulatory affairs working experience, mainly for medical devices. Some knowledge of EU Regulations, FDA and other international regulations and standards
- Demonstrated knowledge in EU MDR/US FDA/AU TGA/NZ Medsafe regulations and guidelines
- Experience with the preparation, review, and submissions such as 510(k), IDE, PMA, CE Technical File/ Design Dossier will be required.
- Ability to develop strategic regulatory plans and to communicate these effectively within the relevant structures.
- Sound skillset in Microsoft Office, Adobe PDF Pro and other IT tools such as Windchill
- Strong verbal and written communication skills
- Ability to effectively work within a team is required.
- Excellent project management and data analysis skills
- Both hands-on and strategic

**Your Background**:

- Tertiary education in BA/ BS in Science, Mechanical, Biomedical Engineering or Regulatory Advanced Degree, with greater than 5 years' experience in medical device or other regulated industry.

**Travel Expectations**:

- Up to 10% travel may be required

EOE/M/F/Vet/Disability

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