Regulatory Affairs Specialist

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.

Duration and Compensation: This is a contract position with a competitive rate with experience and qualifications. The selected candidate may have the opportunity for extension or permanent employment based on performance and company needs.

We look forward to receiving applications from qualified individuals who are passionate about maintaining high-quality standards and driving continuous improvement within our organisation.