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