Regulatory Affairs Specialist

Location Sydney
Contact name: Ethan Keating

Contact email: ethan.keating@medella.life
Job ref: 827
Published: 25 days ago

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

Location: Hybrid - Sydney, Australia

Overview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a focus on In Vitro Diagnostics (IVD). The position will be based in our Sydney office, offering a hybrid work arrangement.

Key Responsibilities:

  1. 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.

  2. Submission Management:

    • Prepare and submit regulatory documents, including 510(k) submissions, CE Mark applications, and other regulatory filings.
    • Collaborate with cross-functional teams to gather necessary information for regulatory submissions.

  3. 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.

  4. 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.

  5. 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.