Global Regulatory Compliance Specialist

4 days ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $90,000 - $120,000
Regulatory Affairs Professional

The primary objective of this role is to provide expert guidance and support with respect to the regulatory environment, at all stages of the life cycle of our products.

The Regulatory Affairs team ensures that management systems are established to enable us to comply with, and readily display compliance with, multiple regulatory frameworks and to support the design, development and manufacture of products which meet regulatory requirements.

You will work closely with internal stakeholders and external regulators to achieve business goals, including:

  • Managing regulatory compliance of existing products
  • Reviewing new and changing policies, regulations and guidance documents issued by global regulatory agencies
  • Maintenance and analysis of corporate and regulatory specific data
  • Initiating and supporting process improvement projects related to operational processes, digital tools and databases
  • Representing Regulatory Affairs on cross-functional business projects

Key Skills and Qualifications:

  • Excellent attention to detail, strong organizational and communication skills
  • Ability to work within a team and also independently
  • Ability to prioritize, coordinate multiple projects simultaneously and work to timelines
  • Agility and flexibility
  • Strong understanding of global regulatory requirements and submission processes

Qualifications and Experience:

  • Bachelor's degree in Engineering, Computer Science, Life Sciences, Regulatory Affairs or a related field
  • Minimum 3-5 years of experience in regulatory affairs within the medical device industry
  • Familiarity with ISO 13485, ISO 14971, FDA 21 CFR Part 820 and other relevant standards and regulations

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