Regulatory Affairs Lead

2 weeks ago

Sydney, New South Wales, Australia Cepheid Full time

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

This position is part of Regulatory Affairs, Global Market Expansion and will be located in Australia. The role will report to the Senior Director, Regulatory Affairs.

**In this role, you will have the opportunity to**:

- Serve in the following: preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to obtain product approvals.
- Mentor and coach team on complex regulatory business initiatives.
- Manage and translate strategy/plan into goals by building repeatable processes that help manage the team's sustained delivery on performance metrics.

**The essential requirements of the job include**:

- Bachelor's degree with 8+ years of related work experience, OR Master's degree in field with 6+ years of related work experience, OR Doctoral degree in field with 3+ years of related work experience; AND at least 2 years supervising people.
- Experience leading regulatory submissions and interactions with regulatory authorities (e.g. TGA) with an in-depth knowledge of global regulatory requirements, standards, and guidelines (including ISO 13485, and US FDA 21 CFR Part 820 Quality Systems regulations).
- Strong written and communication skills; comfortable working in a dynamic multi-functional matrix organization.

**Highly preferred requirements of the job include**:

- Experience in supporting Quality Assurance activities.
- Technical experience within the_ in vitro_ diagnostic or medical device industries.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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