
MedTech Regulatory Affairs Specialist
1 week ago
Job Title: Regulatory Affairs Manager
About the Role:
We are seeking a highly skilled Regulatory Affairs Manager to join our client's organisation. The successful candidate will be responsible for managing regulatory affairs processes, developing and rolling out regulatory strategies, and providing consultation to the business.
Key Responsibilities:
- Day-to-day management of regulatory affairs processes
- Developing and rolling out regulatory strategies for submissions, labelling, post-marketing lifecycle management
- Providing 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
- Developing and enhancing relationships with external agencies
Requirements:
- Bachelor of Science or related degree
- 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
What We Offer:
- A state-of-the-art facility with bespoke, cutting-edge manufacturing equipment and facilities
- The opportunity to play an integral role in diversifying the company's product range
- Work in a high-performing team
- Fantastic, diverse and inclusive culture
- On-site parking
Contact Information:
Please contact Leah Creswick on 0478 193 170 for more information.
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