Senior Regulatory Affairs Associate - Anz

• Broad product portfolio and market leading products
• Global medical device company
• Be a trusted advisor in Regulatory Affairs 
• Supportive team environment  

Your Opportunity

We are looking for an experienced Senior Regulatory Affairs Associate to join our team, and support growth and innovation in Regulatory Affairs at B.Braun.

Reporting to the Senior QA/RA Manager, you will co-ordinate New Product Registrations for Australia and New Zealand including evaluation, submission, tracking and follow up of submissions, and provide regulatory advice and support for a portfolio of company products/services that have to comply with Government Regulations. 

Your Responsibilities

• Manage the process for registering and obtaining regulatory approvals for new/extension and change products with sufficient lead time for market introduction. Ensures all regulatory compliance, submission, and approvals are met.
• Undertake Prostheses Listing (PL) application transactions.
• Assist with the establishment and coordination of all relevant legislative, regulatory, contractual and other compliance processes.
• Prioritise and organise multiples projects and competing priorities for efficient use of time.
• Provide regulatory reports where applicable.
• Attend MTAA Regulatory Affairs Forum and provide feedback to the business on regulatory changes.
• Develop, maintain and strengthen working relationships with health authorities, industry bodies and contract pharmaceutical manufacturers in Australia and New Zealand
• Manage and resolve requests for further information with TGA, Department of Health and MedSafe 
• Interface with commercial, medical and clinical departments to provide expert regulatory input including promotional materials.
• Assist the QA RA Manager in the development and maintenance of company regulatory policies and procedures. 
• Post market surveillance annual reporting (complaint, Adverse Event report, and/or any regulatory body in the assigned country)
• Participate in Quality System Audits by internal / external auditor.
• Knowledge of APVMA regulations 
• Responsible for maintaining regulatory files relevant to ANZ products.

About You

Your background will include:

• Degree qualified in either a Science, Engineering or Technical field.
• Previous experience and relationships within the TGA/Medsafe highly regarded.
• Relevant background in Regulatory Affairs; high degree of understanding of regulatory requirements, scientific methods, and engineering fundamentals.
• Current industry experience in Pharmaceuticals & Medical Device with a good understanding in technical/engineering/medical terminology or can reference literature for understanding.
• Any exposure to Medical Device Regulatory Affairs would be highly regarded.
• Strong interpersonal, oral and written communication skills required.
• Ability to work autonomously in a fast-paced environment and handle multiple tasks and requests.
• Highly developed technical writing skills

About B.Braun

Founded in 1839 and headquartered in Germany, B. Braun is one of the world’s leading manufacturers and providers of healthcare solutions with a diverse portfolio of products and systems. With a global footprint in over 62 countries, B. Braun is committed to sharing expertise and maintaining a painstaking approach to quality, making a significant contribution to improving healthcare. 

All applicants MUST have full working rights in Australia.

Interested? Please click “Apply” online. 

For further information, please contact Manisha Khare at ***************@bbraun.com