Regulatory Affairs Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $120,000 - $205,000

Job Title: Regulatory Affairs Specialist

Our organization seeks an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will possess a deep understanding of global regulations and standards, with a proven track record of developing and implementing effective regulatory strategies.

About the Role:

The Regulatory Affairs Specialist will be responsible for ensuring compliance with global regulations and standards by developing and implementing regulatory strategies. This will involve preparing regulatory submissions, interacting with regulatory agencies/health authorities, and mentoring/coaching team members on complex regulatory business initiatives.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with global regulations and standards.
  • Prepare regulatory submissions and interact with regulatory agencies/health authorities to resolve queries and obtain product approvals.
  • Mentor and coach team members on complex regulatory business initiatives.

Requirements:

  • 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.

Benefits:

We offer a competitive salary and benefits package, including opportunities for professional growth and development.

About Us:

Our organization is passionate about improving healthcare 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.

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