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Regulatory Affairs Specialist

1 week ago

Sydney, New South Wales, Australia Osseointegration International Full time

At Osseointegration International, we're pushing the boundaries of orthopaedic care. As a Regulatory Affairs Associate, you'll be part of a multidisciplinary team dedicated to providing optimum patient outcomes.

We're looking for an individual with a solid track record in regulatory affairs, particularly in orthopaedic medical devices. Your expertise will help us navigate international regulations and ensure our products meet the highest standards.

The role involves managing and coordinating regulatory documentation, ensuring compliance with international standards and laws, determining regulatory requirements for product registrations, and leading regulatory submissions. You'll collaborate with other departments to ensure products meet regulatory requirements.

Responsibilities:

  • Lead the registration of our orthopaedic medical devices in international markets by demonstrating an in-depth understanding of regulatory requirements.
  • Be responsible for the preparation and maintenance of regulatory submissions and relay the regulatory requirements to the product development teams.
  • Liaise with regulatory bodies, including FDA, MDR, and TGA, to ensure all matters related to product registration are well-managed.
  • Provide strategic insights during product development and apply all relevant regulatory requirements to ensure compliant product design and manufacturing processes.
  • Monitor and interpret changes in regulations, advise on the impact of such changes on our strategy, and plan for necessary adjustments to maintain compliance.
  • Ensure submissions and approvals are timely, and all loss of approvals are avoided.
  • Collaborate with internal cross-functional teams to resolve potential regulatory issues and inquiries.

Requirements:

  • Bachelor's degree in a related field. Advanced degree or Regulatory Affairs certification (RAC) preferred.
  • Regulatory Affairs expertise including experience in regulatory documentation, compliance, requirements, and submissions in multiple countries.
  • Extensive knowledge of FDA, MDR, MDSAP, ANVISA and TGA requirements and regulations.
  • Demonstrable ability to interpret and apply regulatory guidance and regulation in practical situations.
  • Excellent written and verbal communication skills and the ability to communicate complex regulatory information in a clear and understandable manner.
  • Strong problem-solving skills, attention to detail, and organizational skills.