Regulatory Affairs Lead

time type Full time

posted on Posted 2 Days Ago

job requisition id R1291084

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.

The Regulatory Affairs(RA) Lead is responsible for regulatory strategy, submissions, license management, in-country testing, and audit support for regulated countries throughout the Asia/Asia Pacific (APAC) region. The Lead will serve as the subject matter expert on cross-functional projects to ensure key performance indicators are met. Provide guidance and training to associates to ensure skilled competencies of global Regulatory standards and requirements at Cepheid.

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 vitrodiagnostic 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.

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world's most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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