Regulatory Affairs Specialist

1 week ago

Sydney, New South Wales, Australia Medella Life Full time

Location- Sydney- Contact name:

  • Ethan Keating
  • Job ref:
  • 827 Published:
  • about 2 hours ago

Job Title:
Regulatory Affairs Specialist (12-month Contract)

Location:
Hybrid - Sydney, Australia

Key Responsibilities:

-
Regulatory Compliance:

  • Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector, with a specific emphasis on IVDs.
  • Monitor and interpret changes in regulations to ensure the company's products meet all requirements.
-
Submission Management:

  • Collaborate with crossfunctional teams to gather necessary information for regulatory submissions.
-
Quality System Support:

  • Contribute to the development and maintenance of the company's quality management system to ensure ongoing compliance.
  • Participate in internal and external audits related to regulatory affairs.
-
Product Lifecycle Management:

  • Support regulatory aspects of product development from concept through commercialisation.
  • Provide regulatory input to product development teams and ensure compliance throughout the product lifecycle.
-
Communication and Collaboration:

  • Liaise with regulatory authorities, notified bodies, and other relevant stakeholders.
  • Collaborate with internal teams, including R&D, Quality Assurance, and Marketing, to achieve regulatory goals.

Qualifications:

  • Bachelor's degree in a relevant scientific or engineering discipline.
  • Proven experience in Regulatory Affairs within the Medical Device sector, with specific exposure to In Vitro Diagnostics (IVDs).
  • Strong understanding of regulatory requirements, including FDA regulations, EU MDR, and other global regulatory frameworks.
  • Experience with preparing and submitting regulatory documents and interacting with regulatory agencies.
  • Excellent communication and interpersonal skills.

Desirable Skills:

  • Familiarity with international regulatory requirements for medical devices.
  • Previous experience in a hybrid work environment.
  • Certifications in Regulatory Affairs would be an advantage.

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