Senior Regulatory Affairs Associate

Benefits

• Work for the global leaders in medical technology
• Attractive/Competitive salary
• Great opportunity for professional development
• Excellent employee engagement
• Flexible working
• Additional benefits, rewards and recognition

About the company

The company offers a diverse array of innovative medical technologies products to help people lead more active and more satisfying lives. They offer a world-class program of medical education and training initiatives to advance expertise and care.

About the opportunity

A great opportunity to work for a successful Fortune 500 company that provides exceptional medical products and services. The role reports to Senior Manager - Regulatory & Reimbursement. You will be responsible for product compliance across all requirements of relevant regulations and legislation while providing mentorship to the team members.

Duties

• Prepare and submit registration applications including complex submissions such as Class III and conformity Assessment applications for required products within the portfolio.
• Prepare reports associated with Regulatory Actions & Post Market Surveillance.
• Process regulatory actions in liaison with Quality and in accordance with the Therapeutic Goods administration (TGA), Medsafe and corporate requirements.
• Develop new regulatory processes and process improvement advice to improve RA compliance and efficiency
• Mentor and train entry-level regulatory associate in team
• Advise on, maintain and process registration changes for required products.

Skills and Experience

• Tertiary qualifications such as an undergraduate science or engineering degree or equivalent
• Minimum 3+ years of demonstrated success in the analysis and interpretation of regulatory documentation and technical writing
• 2-4 years of experience in regulatory affairs and some experience in product management of medical devices would be ideal
• High level knowledge of Australian and international regulatory environments for medical devices.
• Excellent negotiation and communication skills
• Proficiency in MS Office Suite

Culture

Unique and inclusive culture that values people and performance at heart. Recognised as the Best Workplace in Australia.

How to Apply

Click apply or contact Angela Barclay, Associate Director on +61 2 8877 8743 for a confidential discussion.