Regulatory Affairs Associate

1 week ago

Sydney, New South Wales, Australia Osseointegration International Full time

Direct message the job poster from Osseointegration International

Driving Innovations in Orthopedic Medical Devices

Company Description

Osseointegration International is a global orthopaedic provider based in Sydney, NSW. The company provides optimum care by a multidisciplinary team of experts and a long-term clinical follow-up program to assist patients in every step of their journey and performed over 1500 surgeries globally. The organization partners with leading implant manufacturers and distributors worldwide to allow patients access to the latest implant innovation.

Role Description

This is a 6 month contract hybrid role located in Sydney, NSW, with good flexibility for remote work. The Regulatory Affairs Associate will be responsible for managing and coordinating regulatory documentation, ensuring regulatory compliance with international standards and laws, determining regulatory requirements for product registrations, and leading regulatory submissions. The Regulatory Affairs Associate will 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 in those markets.
  • 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 but not limited to 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.

Required Skills and Qualifications:

  • 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.

This is an exciting opportunity for an individual who has a solid regulatory track record in Orthopaedic Medical Devices. Are you ready to use your expertise to help take our products worldwide? Apply now

Seniority level
  • Entry level
Employment type
  • Contract
Job function
  • Legal
  • Industries
  • Medical Equipment Manufacturing
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