Regulatory Affairs Specialist

2 hours ago

Sydney, 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 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.

**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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