Regulatory Affairs Manager

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.The Successful Candidate will enjoy these benefits:

• 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

If this role sounds like you, then please apply with your covering letter and resume in Word format.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
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