Regulatory Affairs Manager

5 months ago


Melbourne, Australia Fuse Recruitment Full time

**Melbourne VIC**

**APPLY NOW**

**Full time**

**We are looking for an experienced Regulatory Affairs Manager to join our client’s organisation**

Our client is a rapidly expanding MedTech innovator and manufacturer. As they go from strength to strength, demand for innovative product development has driven the need for a Regulatory Affairs Manager to join their organisation on a full-time permanent basis.
- This company has a state-of-the-art facility in Melbourne, with bespoke, cutting-edge manufacturing equipment and facilities.
- Play an integral role in diversifying the company’s product range
- Work in a state-of-the-art facility with a high-performing team
- Be part of a fabulous group of people - Fantastic, diverse and inclusive culture
- On-site parking

**Duties and responsibilities include**:

- Day to day management of regulatory affairs processes, along with setting objectives and managing multiple regulatory affairs projects
- Developing and rolling out regulatory strategies for submissions, labelling, post-marketing lifecycle management
- Provide consultation to the business for research capabilities on regulatory solutions
- Maintenance of regulatory licences for local and overseas countries
- Working with other departments to ensure timely delivery of products
- Develop and enhance relationships with external agencies

**We are looking for someone with**:

- Bachelor of Science or related
- Strong experience in a TGA, GMP, FDA, EU IVDR and ISO 13485 environment
- Strong experience within the MedTech space
- Strong leadership skills and proven experience managing a team
- Excellent problem solving skills and time management skills
- Excellent communication skills - Both written and verbal
- Excellent computer skills
- Questions can be directed to Leah Creswick on 0478 193 170.
- At Fuse, we specialise in recruitment for the manufacturing industry and actively source a variety of roles for a broad range of manufacturers. If you are looking for a new opportunity, I'd love to hear from you
- If you know someone looking for a job, refer them to us and we'll give you $500* if we find them a new role
- #SRC-leah-creswick
- #ChooseFuse

**Consultant**:
**Leah Creswick**:
**Team Leader, Manufacturing**:

- 0478 193 170
-

**Reference number**:
BH-29624



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